International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Development and Validation of a Selective Reversed-phase High Performance Liquid Chromatography Method for the Quantification of 1α-Hydroxy Vitamin D2 and its Impurities
G Jaya Sheela, M Satya Babu, Pramod Kumar
Abstract
A selective reversed-phase high-performance liquid chromatography (RP-HPLC) technique was developed for 1α-hydroxy vitamin D2 (Doxercalciferol) related substances analysis. The technique is proficient of eluting various impurities related to process and degradation. To separate both the vitamin D2 Analogs i.e., doxercalciferol and ergocalciferol. HPLC of Shimadzu, provided with autosampler, column oven, quaternary pump and UV detector, were used for development studies. The mobile phase used water and acetonitrile. The diluent used was methanol and detection was examined at wavelength 265 nm. The method is sensitive for doxercalciferol, ergocalciferol, impurity-A and impurity-B; the limit of detection (LoD), value is 0.01% and limit of quantitation (LoQ) value is 0.03%. Linearity of doxercalciferol and related impurities at various concentrations was performed and the obtained correlation coefficient for doxercalciferol is 0.995, ergocalciferol is 0.997, impurity-A is 0.990 and impurity-B is 0.993. The optimized method was validated and demonstrated that the technique is selective, precise, linear, sensitive and accurate. The method is simple, inexpensive and useful for routine testing of doxercalciferol API. In addition, the technique was effectively applied for the elution of both the vitamin D2 Analogs i.e., doxercalciferol and ergocalciferol. Further, the same method is applicable for the determination of assay for these two API’s and the same assay method was validated.

2. Formulation and Ex-vivo Permeation Study of Tamoxifen Citrate Loaded Transfersomal Gel
Gayathri Hariharan, Sangeetha Shanmugamsundaram, Damodharan Narayanasamy
Abstract
Objective: The current study’s objective is to assess the transfersomal gel, administration of tamoxifen citrate transdermally for design of experiments (DOE) Approach. Materials and Methods: Supramolecular clusters with extreme flexibility, known as transferosomes can penetrate untouched animal skin. The formulations were designed by Box-Behnken design (BBD). The ex-vivo skin permeation study of tamoxifen citrate-loaded transferosomal gel was compared with commercial gel and blank drug solution. A total of 100 mg of the maximal drug release (94.32%) from the tamoxifen citrate optimized transferosome formulation demonstrated excellent results. Conclusion: According to this study, the comparatively stable transferosomes represent a promising long-term administration strategy for tamoxifen citrate. According to this study, transdermal drug delivery of skin cancer could be treated by employing transferosomes containing the tamoxifen citrate.

3. Phytochemical Studies and Identification of Bioactive Compounds using High-performance Liquid Chromatography and GCMS of Leaf Extract of Jatropha curcas
Gayathiri Kichenamourty, Chitra Vellapandian
Abstract
Chronic, recurring, and remitting inflammatory disease with an unknown cause is inflammatory bowel disease (IBD). It is a condition that affects people throughout their lives and has many consequences because it is clinically common. Numerous risk factors are still unknown, and the pathophysiology of IBD is still not fully understood. There are a variety of side effects associated with conventional ulcerative colitis treatment. Globally, there is a rise in the use of herbal therapy for IBD. The medicinal plant Jatropha curcas (L.) belongs to the Euphorbiaceae family. It is a biofuel plant with a few pharmacological effects that have been researched. The study’s purpose was to discover and investigate the bioactive components in an ethanolic extract of J. curcas. The leaves of L. J. curcas were gathered, shade dried, crushed up, and gradually extracted with ethanol using the soxhlet percolation method. By using fourier-transform infrared spectroscopy (FTIR) and high-performance liquid chromatography (HPLC), the phytoconstituents in the Jatropha leaf extract were confirmed. Along with the interpretation of mass spectra, the isolated chemicals were identified by contrasting their peak areas and retention times. Due to the discovery of possible, bioactive components as a result of the current inquiry, we are now able to investigate biological activity. After that, gas chromatography-mass spectrometry (GC-MS) was used to analyze the crude extracts. A large variety of secondary metabolites were detected in the extracts’ profile, which was then spectroscopically described. The presence of phytoconstituents, including flavonoids, tannins, and triterpenoids significantly reduces internal inflammation and lessens damage to the intestinal mucosa. Herbal treatments work through a variety of processes, including immunological control and antioxidant activities.

4. Comparative Investigation of Hair Shampoos Formulated Using Different Herbal Extracts
Mugdha Banduke, Akash Gaikwad, Harshada Chattar, Mohini Kuchekar, Bhushan Pimple, Nitin Deshmukh, Harshal Tare
Abstract
Cosmetics have fascinated the human race for ages. Cosmetics have been found to benefit in several ways such as enhancing appearance, protection, cleansing etc. If fortified with the benefit of herbal ingredients, these personal care products have proven to be a boon for many. The current study involves the formulation of seven shampoos using different herbal extracts and their comparative investigation for physicochemical and performance characteristics. Various herbal extracts using components such as coffee, fenugreek, green tea, bringaraj, onion seeds, orange oil, and lemon oil were developed and compared against the marketed standard. The effect of various extracts on the parameters such as surface tension, foam test and foam stability test, viscosity, cleansing test, sag test, dirt dispersion, wetting time and pH was successfully tested. All the formulations were found to be beneficial in eliminating oil, dirt, and dandruff, encouraging smooth, silky hair appearance, fortifying and darkening hair without altering or harming hair tresses. Our findings suggest the incorporation of fenugreek, lemon and orange peels to increase the cleansing ability. However, the inclusion of onion seeds and green tea has been found to be beneficial in the generation and stability of the foam.

5. Formulation and Evaluation of Fenofibrate Dry Emulsion Tablets by Freeze Drying Method
Nikam Aarti, Kamble Ravindra
Abstract
Fenofibrate (FF) is a lipid-lowering agent classified in the biopharmaceutics classification system (BCS) class II with lower solubility and higher permeability. This research work deals with developing FF containing liquid self-micro emulsifying drug delivery system (L-SMEDDS) and converting it into solid SMEDDS (S-SMEDDS) using a lyophilization technique followed by the manufacturing of tablets with enhanced solubility and dissolution rate. L-SMEDDS of FF were manufactured using Tween 80, oleic acid, and transcutol. With the help of the lyophilization technique, this L-SMEDDS was converted to S-SMEDDS using microcrystalline cellulose and finally, immediate-release tablets were developed using S-SMEDDS. The L-SMEDDS showed excellent stability due to zeta potential of -1.69 mV and a globule size of 250 μm. The lyophilized S-SMEDDS of FF showed nearly 58-fold solubility enhancement in distilled water in comparison to pure FF due to the formation of amorphous material confirmed in the X-ray diffraction (XRD) study. The F9 formulation showed 100% drug release within 40 minutes with enhanced dissolution properties compared to conventional tablets. The optimized formulation was robust and stable at the accelerated condition for 3 months. The current research work demonstrates lyophilization as a potential approach to convert the L-SMEDSS to a S-SMEDDS with an enhanced solubility and dissolution rate.

6. Formulation, Statistical Optimization and Stability Study of Ondansetron Films
Mahesh M. Thakare, Sarita Karole
Abstract
Nausea and/or vomiting is common in patients of all ages. Nausea and vomiting can occur for a variety of reasons and may be related to illness or treatment. Careful study of the receptors involved has aided in the selection of drug classes to treat patients (34). This study aimed to prescribe an oral dissolving film of the antiemetic drug ondansetron for treating vomiting patients and nausea and vomiting (NVP) in pregnancy. The goal for optimizing the orally dissolving ondansetron film was to reduce disintegration time and maximize drug release from the film. The formulation of the mouth-dissolving film contains carefully selected additives to impart aesthetic and performance properties such as taste masking, rapid dissolution, physical mouth feel and tactility. From a regulatory perspective, all excipients used in the formulation of oral dissolution films are generally considered safe (i.e., on the GRAS list ) and are approved for use in oral pharmaceutical dosage forms.

7. Formulation and the Study of Finished Products used for Anginal Disease
Charanjeet Singh, Yashwant, Anil K. Gupta
Abstract
Congestive heart failure is a type of disease which is mainly observed due to the improper supply of blood to the heart. In this disease patient feels severe pain in the chest and may cause serious illness. Sudden treatment is needed in this disease to prevent any fatality. Nitroglycerin is the choice of drug for this disease. This study prepares a dosage form that can deliver the drug at a fast rate like a sublingual tablet of nitroglycerin. Sublingual dosage form was manufactured by direct compression method. For the formulation, multiple excipients like super disintegrants, sweeteners and lubricants were used. The finished dosage form was evaluated for different quality parameters. Optimum formulation was compared with the marketed product and kept on the accelerated stability study. Results were observed as satisfactory and comparable with the marketed product.

8. Stable Amorphous Solid Dispersion of Eplerenone Prepared with Water Soluble Polymer by Spray Drying Technique
Kunal Bagul, Atishkumar Mundada
Abstract
Class II in the biopharmaceutical classification system, eplerenone (EPL) is a selective aldosterone antagonist. Due to its poor solubility, EPL has limited bioavailability. Here, an innovative spray-drying method was used to transform a water soluble polymer into an amorphous dispersion of the EPL. Different polymer SOL/EPL ratios were tested to determine EPL’s solubility and dissolution enhancement properties. In order to learn more about the physical and chemical properties of this novel amorphous solid dispersion (ASD), methods like powder X-ray diffraction spectroscopy (PXRD), differential scanning calorimetry (DSC), fourier transform infrared spectroscopy (FTIR), particle size distribution (PSD) using a Malvern instrument, and scanning electron microscopy (SEM) were used. There was no chemical interaction between the binary mixture of EPL and SOL which was confirmed from the FTIR spectra obtained. The enhancement in the solubility and dissolution of EPL and binary mixture prepared were due to the amorphous conversion of EPL in the SOL polymer (amorphous solid dispersion), which was confirmed from DSC thermogram, PXRD spectra obtained and was also confirmed from the solubility study, in-vitro dissolution study. Finally, ex-vivo intestinal absorption study performed on the goat intestine using amorphous solid dispersion and pure EPL, also improved intestinal absorption of EPL through amorphous solid dispersion prepared.

9. Extraction, Characterization and Therapeutic Evaluation of Seeds of Phaseolus vulgaris L. for Weight Management
Yogesh S. Bhide, Jitendra Y. Nehete, Rajendra S. Bhambar
Abstract
The frequency of overweight concerns and obesity is progressively growing in high-income countries in the west and low-income and middle-income countries. Those suffering from these conditions may find that taking measures to cut their carbohydrate consumption and their absorption rate is beneficial. To slow the pace at which glucose is taken into the bloodstream, blocking amylase, a key enzyme in the digestion of carbs, is highly recommended. AIs, or beta-amylase inhibitors, are chemicals found in plants that work to prevent this enzyme from doing its job. Interestingly, the common bean, or Phaseolus vulgaris, has protein-based α‐Amylase inhibitors that regulate the activity of this enzyme through protein-protein interaction. In this article, we cover the numerous extracts of common bean seeds, the protein inhibitors that those extracts include, and what the most recent research has shown about the molecular structure of those extracts and the method by which they exert their inhibitory effects. Evidence for the possible benefits of P. vulgaris protein inhibitors, including clinical research conducted on both animals and humans, is also covered in this article. However, more research is necessary to validate the therapeutic efficacy of the drugs already on the market. This research has the ability to provide a succinct review of the current state of information on P. vulgaris extract and its prospective application as a nutraceutical alternative to control possible weight gain if observed to be successful.

10. Evaluation of Bioactive Potential of the Digera muricata Mart
Nalini Tomer, Mohammad Irfan Ali, Sarmad Moin
Abstract
Digera muricata (L.) mart (Amaranthaceae) is a promising medicinal plant used as a prophylactic, antioxidant, anthelmintic, antimicrobial, allelopathic, and antidiabetic. The present study assesses the quantification of primary and secondary metabolites along with the antimicrobial potential of D. muricata. Qualitative and quantitative phytochemical analysis was undertaken to evaluate secondary metabolites extracted from leaf extracts of D. muricata by using standard methods. The antibacterial and antifungal potential was studied by using the disc diffusion method. A (gas chromatography-mass spectrometry) (GC–MS) study was carried out to recognize the bioactive molecules in the active fraction. D. muricata contained carbohydrates, proteins, steroids, amino acids, cardiac glycosides, coumarin, polyphenol, alkaloids, saponin, tannin, and flavonoids. Results also indicate that ethyl acetate extracts of D. muricata showed significant antimicrobial potential against Streptococcus agalactiae (ATCC13813), Klebsiella pneumoniae (MTCC432), Escherichia coli (MTCC730), Streptococcus pyogenes (MTCC1924), Macrophomina phaseolina, and Candida albicans (MTCC7315). These findings showed that the ethyl acetate extract of D. muricata confined bioactive molecules of therapeutic rank with significant antibacterial and antifungal activity.

11. Preparation, Characterization of Bacterial Cellulose and Chlordiazepoxide Tablets for Oral Drug Delivery
Dada Kodalkar, Ajit Kulkarni, Birendra Shrivastav, Harshal Tare
Abstract
Bacterial cellulose (BC) is a highly purified form of cellulose that offers several benefits, including an ultrafine fiber network, a high water retention capacity, and simple fabrication into desired forms. There has been a recent uptick in BC’s focus on drug delivery for biomedical applications. Studies on prodrug design, controlled-release methods, and pill coating have all been conducted for BC. This research was done to determine if BC might be employed as a medication carrier in chemical and biological formulations. BC microparticles laden with the medication were produced via grinding. Clordiazepoxide hydrochloride (CDP) was used to test the microparticles’ drug loading and release capabilities. Particle morphologies, drug loading efficiency, loaded drug physical state, and drug release behavior were all assessed for the manufactured microparticles. Amorphous microparticles were formed from BC microparticles. An scanning electron microscope (SEM) study found that the microparticles had a nearly round form with an average diameter of 400–500 μm. Drug loading was greater in the renewed BC microparticles (37.57 ± 0.22%) when the concentration of drugs was held constant at 10%. More than 85% of the medication was delivered for all formulations in the first 30 minutes.

12. Cream for Tinea Pedis: Formulation and Validation using Extracts of Curcuma longa, Shorea robusta, and Madhuca indica
Abhinandan Patil, Firoj Tamboli, Dinanath Gaikwad, Dipak Mali, Vijaykumar Pawar, Ashwini Chakote
Abstract

Disease resistance has been linked in large part to the presence of antifungal chemicals in plant tissues. Fungal diseases that occur on the nails, hair, skin, and mucous membrane are referred to as superficial mycoses in tinea pedis, the toe get affected by Trichophyton species or with Epidermophyton floccosum which we call as fungal infection. Tinea pedis is widely spread in the Indian population, particularly in housemaids, farmers and athletes. Usually, there is irritation, erythema, edema, and inflammation at the spreading edge. All the drugs used are natural in origin and widely available in India, so it was decided to formulate the cream using their extracts. The cream is selected as a formulation for incorporation of the herbal drugs because the cream has an elegant appearance, patient acceptability, easy spreadability and ease of application. The local delivery of drugs is more feasible by topical application such as cream base. The rheological behavior of cream showed pseudoplastic flow and shear thinning property. The stability studies of cream state that the cream has good stability. The patient study reveals that the developed cream is tolerated by the patients, with most of the adverse effects being infrequent, mild and transient. Validation is achieved by measuring the attributes that is possible to quantify. Thus, a cream for tinea pedis was formulated using extracts of Curcuma longa, Shorea robusta and Madhuca indica. From the results, it is clear that the developed cream is effective in the treatment of tinea pedis.

13. Estimation of Linoleic Acid in Flax Seed Oil Formulation using a Validated High-performance Thin-layer Chromatograph Method
Lata Kothapalli, Rahul Tupe, Asha Thomas, Vaidehi Raut
Abstract
Linoleic acid, an omega-6 fatty acid present widely in plant seeds and one of the major components among the fatty acids in Linum Usitatissimum L., commonly called as flax seed and represents the content of 12–19% out of the total lipids in flax seed. This work attempted to quantify the Linoleic acid from flax seed oil using the high-performance thin layer chromatography (HPTLC) method with mobile phase, methanol: toluene: formic acid (3:7:1 v/v), and the wavelength used is 254 nm. The method gave a sharp, symmetrical peak at Rf value 0.63 ± 0.02. The method was validated using intracerebral brain hemorrhage (ICH) guidelines and applied to the assay of marketed capsules of flaxseed. It is confirmed that the reported method can help analyze flax seed oil in different dosage forms, along with cosmetic products containing linoleic acid-rich oils.

14. Stability Indicating Quality by Design-based Development and Validation of Bilastine and Montelukast by Ultra Performance Liquid Chromatography Method
Swarupa Bandi, Sreedevi Adikay
Abstract
Background: The current work, which was conducted under the quality by design (QbD) paradigm, aims to establish the optimization of ultra-performance liquid chromatography (UPLC) using the design of experiments and response surface theory, such as central composite design (CCD), in order to achieve a good separation and resolution. Methods: The mobile phase was composed of methanol (20:80% v/v) and 0.1% tri fluro amine (TFA) buffer, and chromatographic separation was performed on column phenomenex C18 (50 mm x 4.6 mm x 2.5 m) at a flow rate of 0.4 mL/ min. Montelukast (MON) and bilastine (BIL) were both detected at 260 nm. The suggested method was approved in accordance with International Council for Harmonization (ICH) recommendations. Results: The created technique successfully separates both BIL and MON with a chromatographic resolution of 6.4. The technique was linear for BIL and MON concentrations of 0.5–3.0 μg/mL and 0.25–1.5, respectively, and recovery rates ranged from 99–100%. The drug compounds had distinct degradation products that were identified in stress patterns. Conclusion: For the quantification of BIL and MON in the combination tablet, a precise, simple, reliable, and accurate UPLC method was designed. According to the method validation, it was possible to successfully separate two medicines from their degradants utilizing aQbD techniques.

15. An Improved Efficient Chromatographic Development and Validation for Quantitative Determination of Rosuvastatin Calcium and Cholecalciferol in Solid Pharmaceutical Tablets Dosage Forms
Kallol Jana, Beduin Mahanti
Abstract
The simple, reliable, sensitive and isocratic analytical chromatography was developed for the estimation, separation and validation of both the drugs rosuvastatin calcium and cholecalciferol in tablets dosage forms. Chromatographic elution was attained by C18 thermo, 250 x 4.6 mm column, with particle size 5 μm and 1.5 mL per minute flow rate using mobile phase as methanol : acetonitrile : triethanolamine (55:45:0.4%). Detection of both drugs were monitored at 265 nm. The retention time of rosuvastatin calcium and cholecalciferol were 1.336 and 6.031 minutes, respectively and overall chromatographic run time was approximately 20 minutes. The establishment of linearity was done in concentration of 70–130 μg/mL ( r2 = 0.995) and 7–13 IU ( r2 = 0.983), respectively in rosuvastatin calcium and cholecalciferol. The limit of detection (LoD) 0.88 and 0.11 and limit of quantification (LoQ) was 2.66 and 0.34 for rosuvastatin calcium and cholecalciferol, respectively. Accuracy (recovery) was between 94.34 to 103.51% and 100.82 to 102.46% for rosuvastatin calcium and cholecalciferol, respectively. The developed and validated chromatographic method was within the acceptable limits for both the drugs with precision, robustness, accuracy, ruggedness, and stability of the solution and the relative standard deviation was less then 2. The proposed chromatographic method is precise, accurate, rapid, time effective, simple, reproducible for routine quantitative estimation of both the drugs rosuvastatin calcium and cholecalciferol in solid pharmaceutical tablets dosage forms.

16. Depression among Adult Diabetics in the UAE
Shatha Al-Sharbatti, Mahir K. Jallo, Muhannad A. Wahib, Jayadevan Sreedharan
Abstract
Background: Diabetes and depression are costly and prevalent chronic medical conditions. Limited data about the relationship between depression and diabetes in the UAE. Objectives: To assess the risk of depression among diabetics in the UAE. Materials and Methods: A cross-sectional study was conducted among 20 -year-old- and above adults attending the medical outpatients of a teaching hospital, Ajman, with no prior diagnosis of depression and who agreed to participate and give informed consent. The participants were recruited conveniently and screened for depression using beck depression inventory second edition (BDI-II) questionnaire. A validated pilot-tested self-administered questionnaire was also used, including information on socioeconomic status, lifestyle, being diagnosed to have diabetes. Results: The study included 775 participants; 189 had depressive symptoms (24.4%). A significant association was found between depression and gender and education level (p=0.001 for both variables). The percentage of depression was significantly higher among participants diagnosed with diabetes (p=0.016). Performing regular physical activity was associated with a lower rate of depression. Multiple logistic analysis showed that the risk of depression is increased by; gender (being a female compared to a male, or: 2.374 (CI: 1.644 – 3.428, p <0.001); having a lower education level compared to a higher (or: 1.744, CI:11.155 – 2.635, p=0.008); being diabetic (or 1.656, 1.125 – 2.436, p=0.01). Performing physical activity reduces the risk for depression (or 0.521, CI: 0.298-0.909, p=0.022). Conclusion: Diabetes increases the risk of depression. Predictors of depression are gender and having diabetes. Performing physical activity reduces the risk of depression.

17. Development and Validation of an Analytical Method for the Simultaneous Estimation of Azadirachtin and Camphor in a New Herbal Formulation
Avani Khristi, Swati Patel, Yukti Wagh
Abstract
Background: High-performance liquid chromatography (HPLC) is an analytical tool for determining the quality of a drug product. Separating, identifying, and quantifying the various drugs should be able to HPLC methods. To quantify azadirachtin and camphor, a novel HPLC technique was created that is sensitive and selective. Objective: The analysis of azadirachtin and camphor has been designed and verified using a simple, efficient, selective, and precise HPLC technique. Material and Method: With the help of an HPLC C18 column (4.6 x 250 mm, 5 m), a mobile phase made up of buffer (pH adjusted to 3.0 with orthophosphoric acid) and acetonitrile in the ratio 15:85, flow rate of 1.0 mL/min, and column temperature kept at 35°C, good chromatographic separation was achieved in the current study. The resulting effluents were seen at 294 nm using a UV-visible detector. Result and Discussion: Sharp peaks for azadirachtin and camphor were found at retention times of 3.5 and 4.8 minutes, respectively, during the detection process at 294 nm. Over the concentration ranges of 0.1–0.9 g/mL for azadirachtin and 20–180 g/mLfor camphor, the calibration curve was linear. According to International Council on Harmonisation (ICH) guidelines, the method was verified for accuracy, precision, repeatability, specificity, robustness, and detection and quantification limits. Conclusion: The proposed method has specificity, accuracy, and sensitivity, with an excellent linear.

18. Effectiveness of Syzygium aromaticum Extract in Prevention of Diabetic Retinopathy in Experimental Animals
Ashutosh Aggarwal, Tapas C. Nag, Suresh K. Gupta, Bhartu P. Srinivasan
Abstract
Aim of the study: Syzygium aromaticum has been reported to possess aphrodisiac, stomachic, carminative, antispasmodic and anti-cataract properties in traditional ayurvedic medicine. The current study determined the efficacy of S. aromaticum alcoholic extract in the prevention of diabetic retinopathy in rats with type 2 diabetes. Materials and Methods: Type 2 diabetes was induced in neonatal rats with streptozotocin. The effect of S. aromaticum alcoholic extract in different doses on glycemic parameters, lenticular changes, vessel diameter, antioxidant enzymes, inflammatory markers and thickness basement membrane of retinal capillaries was assessed with electron microscopy. The results of the treatment groups was compared with that of the diabetes control group. Results: The treatment of diabetic rats with S. aromaticum alcoholic extract at different doses significantly reduced blood glucose, glycated hemoglobin, lenticular changes, vessel diameter, inflammatory markers and thickness of basement membrane of retinal capillaries and antioxidant enzymes status. Conclusion: S. aromaticum alcoholic extract may be used strategically to prevent diabetic retinopathy.

19. Formulation and Characterization of Herbal Ingredients based Shampoo
Vivek Kaushik, Rakesh K. Meel
Abstract
Shampoo is one of the cosmetic items that uses surfactants as its principal ingredient. When used as directed, the shampoo will clean the hair of surface grease, filth, and skin debris without having an unfavorable effect on the user. Shampoo is now used to promote hair growth and stop hair loss in addition to cleaning debris from the hair and scalp. The shampoo was prepared using amla extract, ritha extract, shikakai extract, bhringraja extract, henna extract, neem extract, and kalonji extract and evaluated for pH, wetting time, doaming properties, detergency ability, surface tension measurement, viscosity percent of solids, skin irritation test and stability test. It was concluded that sodium lauryl sulfate is very toxic to the hair. It damages the morphological integrity of the hair fiber, whereas natural conditioners protect hair morphological integrity and provides consistency and shine to hair.

20. The Impact of Generic Drug User Fee Act on Generic Drug Export from India
Rajender Singh, Swati Singh, Anil Kumar, GT Kulkarni, Arti Thakkar
Abstract
Generic drugs are drugs that have a similar active ingredient, dosage type, strength, and route of administration as a brand name medication. India is the hub of generic drugs and exports to various countries. The regulations for generics have been evolving through the years for better control of the price and quality of generic drugs. In this study, we have formulated a questionnaire consisting of questions on review time, communication with authority, the quality of products, and future expectations of the industry. Most people agreed that there had been a change since the introduction of generic drug user fee act (GDUFA). It has helped in reducing the review time of backlog applications, quick review for new applications, and raised certain expectations from the industry for the future of GDUFA. Communication has also improved between the industry and the food and drug administration (FDA), which has helped the applicant better understand the expectation of the authority.

21. Synthesis, Biological Evaluation and In-silico Studies of 3-((4-(6-(Substitutedphenyl)-2-Mercaptopyrimidin-4-Yl) Phenyl) Imino)- 1-((Dimethylamino) Methyl) Indolin-2-One
Perla Swathi, S. Raja
Abstract
A novel isatin and pyrimidine prototype derivatives 3-((4-(6-(substitutedphenyl)-2-mercaptopyrimidin-4-yl)phenyl)imino)- 1-((dimethylamino)methyl)indolin-2-one were synthesized and designed from the intermediate chalcones. The produced components were characterized, anti-tubercular and antimicrobial screening was done by agar dilution and agar-cup plate methods, respectively. From the studies, it was revealed that derivatives 5e, 5h and 5i showed increased potency. Further in-silico studies were carried out by molecular docking with the interaction of target components 5a-5j within the Mycobacterium tuberculosis enoyl-acp reductase enzyme (1ZID), drug likeness, and pharmacokinetic parameters were measured by osiris property explorer and molinspiration online toolkit respectively.

22. Cleaning Validation: A Crucial Step in Assuring Quality During Pharmaceutical Manufacturing
Saurabh Dahiya, Diwan Chand, Yachika Goyal, Chanchal Sharma
Abstract
Cleaning procedures for manufacturing equipment have been shown to prevent product contamination through the cleaning validation process. This review aims to understand how the cleaning validation plays a critical role in managing contamination or cross-contamination issues during good manufacturing practices (GMP). Emphasis on the quantity of cleaning required for the machinery, the elimination of contamination during manufacturing procedures are discussed here. The article describes various cleaning agents as well as sampling methods for cleaning equipment. Focus is laid on the elements of cleaning validation, objectives of the cleaning validation, regulatory significance of requirements for cleaning validation, etc. Also, it provides information on the different cleaning standards to meet regulatory requirements by the pharmaceutical industry.

23. A Novel Stability Indicating Reversed Phase Ultra Performance Liquid Chromatography Method for Estimation of Asciminib its Bulk and Tablet Formulation
Dandamudi S. Priya, Shivakumar Gubbiyappa, Vasanthi Rangapuram
Abstract
The key objective of the proposed study was to creat and validate an economical, perceptive, specific, reliable and simple reversed phase ultra-performance liquid chromatography (RP-UPLC) method with better response was anticipated for the investigation of asciminib bulk powder and its tablet form. UPLC system (WATERS, Model-2695) connected with PDA (Model-2996) detector was opted to made the present method. To separate asciminib proficiently, method conditions such as C18 column (50 x 4.6 mm, 1.7 m), mobile system of trifluoro aceticacid (TFA) in water (0.1%) and acetonitrile in 75:25 v/v, 0.3 mL/min flow rate and 260 nm wavelength were used as optimized chromatographic conditions. The anticipated method was validated by the ICH specifications. The retention time of asciminib was noticed at 0.925 minute with good efficiency, respectively. Linearity was noticed for concentrations ranging fom 5 to 30 μg/mL of asciminib with R2 value of 0.999. The %RSD of both system and method precision was assessed in the range of 0.49 to 0.86. The percentage recovery of asciminib was in the range of 100.06–100.6%. The logarithm of the odds (LoD) and limit of quantitation (LoQ) of asciminib determined to be 0.23 and 0.69 μg/mL correspondingly. The results confirmed that the projected technique was economical, simple, responsive and precise. Exploration of asciminib under various FD environments confirms the stability representing the nature of the stated method. The proposed UPLC method is extremely valuable in the separation and estimation of asciminib.

24. Solid Dispersion of Dolutegravir: Formulation Development, Characterization, and Pharmacokinetic Assessment
Monika Bhairam, Shiv S. Shukla, Beena Gidwani, Ravindra K. Pandey
Abstract
A recently authorized antiviral drug called dolutegravir has solubility problems and could be a Biopharmaceutical Classification System (BCS) class II candidate. The current study aimed to improve dolutegravir’s solubility and efficiency by employing the solid dispersion method. Different ratios of hydrophilic polymeric carriers, including polyethylene glycol (PEG) 6000, polyvinyl pyrrolidone (PVP) (30K), and hydroxypropyl methylcellulose (HPMC), were used. Dolutegravir (DTG) and soluplus were produced as a solid dispersion at 1:5 ratio using the solvent evaporation method. A variety of techniques were utilized to describe the solid state, including powder X-ray diffraction (XRD), differential scanning calorimetry (DSC), and fourier transform infrared spectroscopy (FTIR). Produced solid dispersion did not reveal any physicochemical interactions between the DTG and soluplus, but the X-ray diffractogram clearly showed that the drug’s crystalline state had transformed to an amorphous state. DTG was released quickly from solid dispersion (92%) compared to pure drug (10.12%), physical mixture (22.06%), and commercially available DTG (62.90%). The formed solid dispersion’s drug release kinetics was in line with the Higuchi Model. Finally, the rapid drug release from the solid dispersion formulation showed higher Cmax (15.25 ± 0.40 μg/mL) compared to the physical mixture (5.11 ± 0.20 μg/mL) and pure drug (4.91 ± 0.73 μg/mL). DTG’s enhanced bioavailability in experimental wistar rats (AUC: 147.99 ± 23.86 μg/h/mL) further supported this when compared to the AUC of animals administered with physical mixture (52.35 ± 4.32 μg/h/mL) and pure drug (43.32 ± 3.13 μg/h/mL). Thus, it could be inferred that by employing the solid dispersion delivery system and the hydrophilic carrier, soluplus, the bioavailability and dissolution profile of DTG could both be improved, which could be expected to improve the drug’s effectiveness in treating HIV/AIDS.

25. Development and Analytical Method Validation for Simultaneous Estimation of Evoglptin Tartrate and Metformin Hydrochloride in Combine Dosage Form
Aesha A. Patel, Manisha C. Kotadiya, Bhakti Shah
Abstract
Metformin hydrochloride is a diabetes medication that is used orally. Evogliptin tartrate is a dipeptidyl peptidase-4 (DPP-4) inhibitor which has been authorized as a new and powerful treatment in the process of reducing glucagon-like peptide 1 (GLP-1) deficiency while increasing insulin production and decreasing glucagon levels. The current study created a simple, highly exact, and rapid reverse phase high-performance liquid chromatography (RP-HPLC) approach for the simultaneous measurement of metformin hydrochloride and evogliptin tartrate in their combined dose form. High-performance liquid chromatography (HPLC), was performed on a phenomenex Luna C18 column with a mobile phase of water 25: acetonitrile 75 (25:75) at a 1.2 mL/min flow rate, with detection at 210 and 230 nm for metformin hydrochloride.and evogliptin tartrate. The validation method comprised of several variables like linearity, accuracy, selectivity, precision, robustness and specificity. The retention time of the metformin hydrochloride and evogliptin tartrate was 2.009 and 2.956 minutes, respectively. The method procedure linear responses of metformin hydrochloride and evogliptin tartrate was found to be 1 and 0.997, respectively. The percent relative standard deviation was less than 2% for intraday variation/precision, interday variation/precision, intermediate ruggedness, and robustness. The projected technique produced excellent results for many dependent variables. The projected method showed outstanding results with respect to different dependent and independent variables like limit of detection and limit of quantitation, suitability of system, linearity range etc., linearity, accuracy, precision, and specificity. The results were within the acceptance criteria given in ICH guideline.

26. Exosomes as Crucial Player in Insulin Resistance and Obesity: Potential Therapeutic Approach
Shreya Sood, Sushma Devi, Thakur G. Singh, Nishant Yadav, Parveen Kumar, Arindam Chatterjee
Abstract
Increasing obesity has become a serious health problem worldwide in recent years, both in adults and children. Obesity can lead to numerous diseases such as osteoarthritis, diabetes, cardiovascular and respiratory diseases, and other metabolic disorders. In addition, obesity is considered one of the most common causes of insulin resistance in the body. Moreover, obesity disrupts normal insulin physiology, resulting in impaired insulin signaling and other intrinsic abnormalities such as poor glucose movement, phosphorylation, and decreased glucose oxidation and glycogenesis. Therefore, it is necessary to find an effective treatment for such conditions. Recently, exosomal therapy has been proposed as one of the alternative approaches to treat metabolic diseases. Exosomes are endosome-derived extracellular vesicles that circulate in body fluids such as mucus, blood plasma, urea, etc., transfer molecules and signals from one cell to another, and thus are involved in various normal and pathological processes in the human body. It has been discovered that exosomes play a role in processes related to obesity, such as adipocyte differentiation, angiogenesis, inflammation, etc. The current study reviewed exosomes’ role in the development of insulin resistance associated with obesity and possible targets.

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