International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1.Comparison of Bioactive Components of Clove Buds as Extracted by Two Different Methods and Analyzed by Gas Chromatography Triple Quad Time-Flight Technology
Kareem A.A. Mohammed, Ashraf Abdel-Hamid F. Wasfy, Mohamed S. Bazalou
This study was carried out to compare the bioactive components of cloves (Syzygium aromaticum bud.) ethanolic extract using both maceration and ultrasound-assisted (sonication) techniques. A total of 101 compounds were identified by gas chromatography triple quad time-flight (GC-Q-TOF) analysis including 48 ,43 for Maceration and Sonication respectively. Regardless of the extraction method utilized Epizonarene, Cyperene, 1R, 4R, 7R, 11R-1, 3, 4,7-Tetramethyltricyclo [,11)] undec-2-ene, δ-Cadinene, 1S, 4R, 7R, 11R-8-Hydroxy-1, 3, 4, 7-tetramethyltricyclo [,11)] undec-2- ene, 2’,3’,4’ Trimethoxyacetophenone, Tributyl aconitate, Desomorphine, trimethylsilyl ether, 4,5,6,7-Tetrahydroxy-1,8,8,9- tetramethyl-8,9-dihydrophenaleno [1,2-b]furan-3-one, Nonacosane Tritriacontane, γ-Sitosterol and Acetic acid, cedrol ester were the main components of cloves. a comparison was made between the two methods , the maceration strategy gave a whole of a chemical component in cloves by long-time extraction; Whereas sonication gave palatable extraction effectiveness and gave comparably comes about to those of maceration with short extraction time, so sonication technique with GC-Q-TOF may well be valuable and suitable for the quick extraction.

2. A Validated Specific Stability-Indicating Reversed-Phase High- Performance Liquid Chromatography Assay Method For L-Ornithine L-Aspartate and Silymarin and their Related Substances and its application to Dissolution Studies
Bhavani Podili, Bajivali Shaik, Prasada R. Kammela
The present study was aimed at the development and successive validation of a novel, simple, sensitive and stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method for quantitative calculation of L-ornithine l-aspartate (LOLA) and Silymarin (SL) and also their relavent substances in bulk and pharmaceutical dosage forms. The chromatographic technic was optimized using the impurity-spiked solution. The separation of all the two active components and their impurities was achieved by a chromatographic method with a Agilent Eclipse XDB-C18, 150×4.6 mm, 3.5 µ column, using gradient elution with mobile phase A consisting of mixture of 0.1% orthophosphoric acid and water and acetonitrile as mobile phase B. The instrumental settings included a flow rate of 1.0 mL/min for both related substances and assay, a detector wavelength of 225 nm, by using a Photodiode Array Detector (PDA) detector. The established method was validated according to the current International Conference on Harmonization (ICH) requirements. The detection limit and the limit of quantification for the two active components and their related impurities were established with respect to test concentration. The calibration graphs plotted were linear with a regression coefficient R2 > 0.999, indicating the method’s linearity was within limits. Recovery studies were satisfactory, and the parameters such as specificity, linearity, accuracy, precision and robustness were determined as part of the method validation. Moreover, using the same method dissolution study was performed on active pharma ingredients to estimate the recovery. The obtained results were within the range of acceptance criteria. These results suggest that the developed method was found to be applicable for routine analysis for testing chromatographic purity of LOLA and SL and it can be utilized to calculate both active ingredients and their impurities in tablet dosage forms.

3. Quality Assurance Analysis of Branded Marketed Preparation Vs. Generic Drug Product of Ofloxacin Tablets: Evaluation of Pharmaceutical Characteristics under Short-Term Accelerated Conditions
Yamu B. Rahangdale, Fahimuddin S. Kazi, Debarshi K. Mahapatra, Ujwala N. Mahajan
Ofloxacin is a 4-quinolone derivative with therapeutic activity against various gram-positive, fastidious gram-negative aerobic, facultative, and obligate anaerobic bacteria. It is available both in the form of branded products and generic products where both have been seen to have different quality, physicochemical, and stability characteristics. The present exploration involved investigating the quality attributes (assay determination and Impurity testing), physicochemical test (physical appearance of tablets, packaging and labeling of tablets, Tablet diameter and thickness, Weight variation test, Hardness test, Disintegration test, and In vitro dissolution study), and accelerated stability study (1, 3, and 6 months under temperature 40 ± 2°C and humidity 75 ± 5% RH) of a branded ofloxacin product and five different generic ofloxacin products available in the Indian market as per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (Q2 and Q3) and the United States Pharmacopeia (USP) guidelines. A comparison between the branded product and the generic products has been made in terms of the quality attributes. The study will open new doors of analysis of pharmaceutical quality assurance and provide avenues for both branded products and generic products to maintain the quality attributes on a regular basis.

4. Amentoflavone–A Probable Candidate for Drug Development
Sreeshma L. Sadasivan, Bindu R. Nair
Molecular docking is one of the most popular and user friendly computational technologies that helps in investigating, interpreting, explaining and identifying the molecular properties of a drug or ligand. In the present investigation, two ligands were tested against six receptor proteins that have pathological significance. The ligands were the synthetic drug, tamoxifen (an oral tablet for cancer treatment), and the test drug Amentoflavone (a biflavonoid reported to be present in two species of Biophytum). The target proteins (PTP1B, hPPARγ, iNOS, VEGF, VEGF2, and VEGFR2) selected for the present study, were retrieved from Protein Data Bank. During the molecular docking studies, the measure of interaction between the proteins and ligands were performed using the LibDock program (the score ligand poses protocol) from Discovery Studio, version 4.0 (Accelrys, San Diego, CA, USA) by calculating the libdock score. The present study results showed that the highest libdock score was between the protein PTP1B and amentoflavone (139.48), which was greater than the highest libdock score for the synthetic drug, tamoxifen (122.33). For tamoxifen, the libdock score was highest for iNOS. The number of hydrogen bonds, the absolute energy, bond type, bond distance and information about the amino acids involved in docking were calculated. It appears that the tested drug, amentoflavone has a greater interaction, revealing its significant role in pathological situations especially cancer and may be chosen as a candidate drug after conducting well-designed in vitro and in vivo studies. The present study reveals the utility of amentoflavone against these specific receptor proteins and may be considered a lead compound for drug development.

5. Estimating the Ephedrine Hydrochloride and Olanzapine Simultaneously in their Pharmaceutical Forms (Tablets) by Derivative Ratio Spectra Method
Imad T. Hanoon, Thamer J. Mohammed
Ephedrine and olanzapine drugs have been simultaneously estimated by applying the derivative of ratio spectra method. It appeared that the method is rapid, sensitive, accurate and does not need beforehand separation of components to solve the great overlapping among spectra. After setting titration curves for ephedrine and olanzapine, it was found that the scope of the concentration for both drugs was between (6–24 It was also found that recovery ranged between (100.14 100.54) and (100.89102.32), and values of relative standard deviation (RDS %) (0.2346–0.5736) and (0.12450.6404). ER% values reached between (0.0051–0.3300) and (-0.0700–0.02013) for both drugs respectively. The method was applied on some pharmaceutical preparations, and it was found that it was salutary well, which makes  themethod applicable for drug production companies.

6. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Oxyclozanide and Tetramisole Hydrochloride from Formulation
Kanan Gamit, Niraj Vyas, Anjalee Shukla, Vipul Patel, Ankit Anchliya
A simple, precise, accurate, and rapid high performance liquid chromatography (HPLC) method has been developed and validated for the determination of oxyclozanide and tetramisole hydrochloride simultaneously, in combined pharmaceutical solid dosage form. The mobile phase used was mixture of solution (2 ml TEA in 1 litre milli-Q water, pH adjusted to 3 with OPA) and acetonitrile (30:70 v/v). Flow rate was set to 1 ml/min. The detection of Oxyclozanide and Tetramisole Hydrochloride was carried out on absorbance detector at 215 nm. Results of the analysis were validated statistically .

7. Scaffold Bearing 1, 3, 4-oxadiazole as Promising Antimicrobial Agents
Katiyar Pratima, Manjul P. Singh
Background: The derivatives of heterocyclic ring 1,3,4-Oxadiazole are used as an antimicrobial agent for the treatment  of microbial infections. Objective: In this study, a new series of benzyl moiety possessing 1,3,4-oxadiazole derivatives have been synthesized by the reaction of 4-(benzylamino) benzohydrazide with substituted aromatic acids in the presence of cyclizing agent phosphorus oxychloride. Method: The structures of synthesized compounds were analyzed by chromatographic data and characterized by spectral analysis (FT-IR, 1H-NMR, C13 NMR and mass spectrum). All synthetic derivatives were evaluated for their in-vitro antimicrobial activity against selected microbial strains; few listed in “priority pathogens” by World Health Organization (WHO). Antibacterial activity of synthetic compounds were assayed against two gram-positive strains Bacillus subtilis, Escherichia coli, and two gram-negative strains Staphylococcus aureus, Pseudomonas aeruginosa. Antifungal activity of synthetic compounds was screened against Candida albicans and Aspergillus spp. The potent derivatives were subjected to in-silico molecular docking studies with enzyme peptide deformylase. Results and discussion: in-vitro antimicrobial assay indicated that compounds 1f, 1j, 1i, 1h and 1g exhibited good antimicrobial activity as compared to commercially available antibiotics Cefixime and Econazole drugs. Conclusion: In this novel series of benzyl moiety containing 1,3,4-oxadiazole derivatives, five compounds exhibited  potent antimicrobial activity against selected microbial strains.

8. Development and Validation for Estimation of Flibanserin in Bulk and Dosage Form
Manjaramkar D S, Hamrapurkar P D, Kaple S R
The Present study described new, simple, accurate precise, development for estimation of Flibanserin by reverse phase high performance liquid chromatography (RP-HPLC) method. The chromatographic method standardized using C18 column (Inertsil ODS 3, 250 x 4.6mm x 5 μ) and mobile phase containing 0.01M Ammonium acetate buffer pH 5(pH adjusted with GAA): acetonitrile (30:70 v/v) at flow rate of 1mL/min the eluents were detected by DAD detector at 257 nm. The retention time was found to be 5.9. The system suitability parameters for Flibanserin such as theoretical plates and tailing factor, were found 15724 &1.03 respectively. The linearity study of Flibanserin was found in a concentration range of 1–3 µg/mL and correlation coefficient (r2) was found to be 0.9995, % recovery was found to be at each level was 99.76–100.73% RSD for interday and intraday precision was found 0.74–0.48%. The analytical method was validated and applied on a marketed formulation.

9. Levels in Hypertensive Patients with G-6A AGT Treated With Angiotensin II Receptor Blocker: A Preliminary Study
Mohammad S. Rohman, Amelia Iradany, Imama Maslahah, Mifetika Lukitasari, Hidayat Sujuti, Risa Ramadhiani, Akhiyan H. Susanto
The existence of genetic variant -6 abnormal glucose tolerance (AGT) is thought to be a functional area that affects the basal transcriptional activity resulted in increased angiotensinogen levels. Single nucleotide polymorphisms (SNP) of G-6A was genotyped by using polymerase chain reaction (PCR) followed by sequencing. Serum angiotensinogen levels were measured using ELISA. In the present study, there was no statistical difference of baseline angiotensinogen levels found among genotypes. Also, there were no significant differences found in angiotensinogen levels as well as in the changes of angiotensinogen levels after a 5-month treatment of angiotensin II receptor blocker (ARB). There was also no statistically significant correlation between blood pressure and angiotensinogen levels at baseline among genotypes. However, mean SBP after 5 months of ARB treatment was found to significantly correlate with serum angiotensinogen levels in patients with AA genotype (p = 0.05; r = -0.28) but not with other genotype. However, this preliminary study should be followed by increasing the sample size to confirm the result.

10. Development and Validation for Estimation of Prucalopride Succinate in the Bulk and Solid Dosage Form
Ashwini S. Chawathe, Purnima D. Hamrapurkar
Quality by design (QbD) based analytical method development and optimization has proved to be of immense importance in the pharmaceutical industry. It has been used in the drug development stage to identify and optimize critical parameters and evaluate its effects on the critical quality attributes. An attempt was made to develop and validate a reverse phase-high performance liquid chromatography (RP-HPLC) method for the determination of Prucalopride succinate in bulk form and tablet formulation using QbD approach. The Box-Behnken design was used for screening where the effect of buffer pH, % ACN and flow rate (critical parameters) on retention time, number of theoretical plates (NTP), and symmetry factor (critical quality attributes) was evaluated. The developed method was validated according to guidelines of the International Conference on Harmonization (ICH). An isocratic mode of elution comprising of 0.01M ammonium formate with pH 5.0 and acetonitrile (ACN) in a ratio of 77:23 v/v as mobile phase at a flow rate of 1.0 mL/min over Inertsil ODS C18, 250 mm x 4.6mm x 5μmcolumn at 27℃ temperature was maintained. A Photo-diode array (PDA) detector was used for detection at 226nm. The method showed a linear response with correlation coefficient value of 0.9987 for Prucalopride succinate which was within the limit (correlation coefficient ≥ 0.995). The limit of detection and limit of quantification (LoQ) was found to be 0.2 µg/ml and 0.8 µg/ml, respectively. Forced degradation studies were also carried out.

11. Risk Assessment of Product Before the Regularization of the Process
Simantini Satapathy, Gowrav M. Prakash, Chethan T. Prabhudevaiah, Hemanth K. Somareddy
Risk or uncertainty are two words frequently used and replaced by one another. In Wherein case of uncertainty, the output is unknown; risky situations give the possible outcomes and the necessary arrangements to deal with it. Thus, risk can actually be quantified, whereas uncertainty cannot be. The study discusses the assessment of the risk involved in different cases that were tried during the procedure. The process of determining the severity and likelihood of adverse effects that may result from exposure to chemical, biological, or physical hazards is known as risk assessment. It is an essential part of the modern advanced pharmaceutical quality. This study provides a general overview of risk assessment which was done before regularization of the process in a pharmaceutical industry (API Plant). It is important to identify the potential causes and risks involved in the manufacturing process before the regularization of the process and suggest the additional controls or CAPA to be taken in case of process identified as a high-risk category.The paper covers the identification of risks that are associated with the process. Thereafter, risk priority number is found out which would help us in comparison of different risks outlined. Subsequently based on the severity, corrective measures are suggested. The study concludes by ensuring that process of continuous quality improvement can be made. Associated riskhave been assessed and controls found to be effective.

12. Stability Indicating RP-HPLC Method Development and Validation for the Determination of Naproxen Sodium in Bulk Drug and Tablet Dosage Form
Pushpa latha E, Sailaja B
A simple, rapid, accurate, precise and reproducible stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method for the estimation of Naproxen sodium in bulk and tablet dosage form was developed and validated as per ICH guidelines. The separation was done using Kromosil C18 150 x 4.6mm, 5µ column. The mobile phase (Buffer and Acetonitrile 50:50%v/v) was pumped at 1.0ml/min and effluent was detected at 220 nm using a PDA detector. The retention time was 2.20 ± 0.1min and the method produced linear response in the concentration range of 2-12 µg/mL (r2- 0.999). In recovery studies, %RSD from reproducibility was found to be below 2%. LoD and LoQ were 0.95 µg/mL and 2.88 µg/mL respectively. The drug was subjected to different stress conditions such as acidic, alkaline, oxidative, photo thermal and hydrolysis. The drug showed more degradation in acidic condition and no degradation was observed in hydrolysis and photo condition. The developed RP-HPLC method was found to be effective, sensitive and specific for the estimation of Naproxen sodium in bulk and tablet dosage form.

13. A Novel Stability Indicating RP-UPLC Method for the Estimation of Ertugliflozin in its Bulk and Tablet Dosage Forms as per ICH Guidelines
Sanapala Srinivasa Rao, A. Vijayalakshmi
A simple, exact, precise strategy was developed for the assessment of Ertugliflozin by reverse phase ultra performance liquid chromatography (RP-UPLC) process. Chromatographic conditions used are fixed stage like Dikma Endeversil C18 (2.1 x 50mm, 3µm). Versatile phase synthesis of 0.1% Octane Sulphonic corrosive: 30:70 v/v acetonitrile and flow rate were maintained at 0.2 ml/min, 226 nm detection frequency, 30oC temperature. The linearity analysis was conducted at 50 to 150 percent range, and R2 was found to be 0.999. The accuracy was found to be 0.6 for repeatability and 1.0 for intermediate precision. Individually, the LOD and LOQ are 2.98μg/ml and 9.97μg/ml. Ertugliflozin validation investigations have been conducted under all circumstances. The edge of virtue was more than the point of purity and exists to a reasonable level.

14. Chemical Analysis of Ginger Rhizomes and Sensory and Microbial Evaluation of Ginger Juice during Storage
Sara T. Hadi, Hbdulhakeem D. Hussien, Maher A. Abed, Hussein J. Alhadithi
Chemical analysis was performed for fresh ginger rhizomes and sensory evaluation of the juice was done. The microbial content of the juice was estimated during storage at 25°C for three months. Results of chemical composition showed that moisture, protein, lipid, ash, carbohydrate and fibers were 85.29, 1.65, 0.95, 0.98, 11.50 and 2.23%, respectively. Total acidity was 0.12%. Results of sensory evaluation of ginger juice prepared using sugar, citric acid and potassium meta-bisulfate that the degrees given for color, flavor and spicy taste were acceptable. General acceptance values were within the allowances since they were between 5 and 6 according to the acceptable to very good acceptable measurement. Results of microbial analysis of the juice samples indicated that the total count of bacteria was low and within the allowances. Total count of  aerobic bacteria and molds were increased during the three months of storage at 25°C.

15. Adenovirus and Bacterial Pathogens Isolated from Eye Infections
Sharmeen N. Majeed, Najat A. Zaman
Background: Τo performs an investigation of viral and bacterial conjunctivitis among conjunctivitis cases recorded at the Azadi Teaching Hospital from January through December 2019. Objective: The present study was conducted to investigate the causes of viral and bacterial eye infections, which included inflammation of conjunctivitis. Methods: A structured questionnaire containing demographic and clinical data was developed in order to collect data on the cases. Eye swab specimens were collected and detection of adenoviruses (AdVs) was performed by the SAS Rapid Adeno test, while bacteria were isolated and Identification by API 20E and vitek 2. Results: Culture investigation showed that out of 130 samples, 58 (44.61) of them have showed positive bacterial growth,53.44% male and 46.55% female,72(55.38) samples have showed no bacterial growth. The most common bacteria isolated were Staphylococcus aureus, which showed a high occurrence of 19 (32.75%), While other bacteria were less than S.aureus. Out of 80 cases 30 cases were diagnosed with viral origin (63.33% male and 36.66% female). Conclusions: SAS Rapid Adeno testing could identify the cause of viral conjunctivitis; this study is one of the very few studies on viral and bacterial conjunctivitis in Kirkuk City. These results demonstrate the need for a control program for outbreaks of viral and bacterial conjunctivitis.

16. Insect Cell Line Development, Maintenance and Susceptibility to Viral Infection: A Review
Ibrahim A. Ahmed, Yaseen I. Mamoori
In the last two decades, great attention has been directed to insect cell culture technology due to its useful role in biotechnology applications. For instance, they have been used to produce recombinant therapeutic proteins, vaccines, biopesticides as well as it is used in gene therapy. A few insect cell lines are available in the markets compared to the huge number of insect species. Establishing an insect cell line requires intensive effort and patience. Particularly, in the early stages of developing a cell line, normally, there will be many obstacles, such as microbial contamination and cell adaptation to the new environment. Finding a good method for tissue disinfection and providing suitable growth conditions such as insect cell culture media and temperature are considered one of the critical keys to developing successful cell lines. This review discusses the requirements to develop insect cell lines, maintenance, and viral infection.


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