International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Nutriciological Aspects and Quality Control of Non-starch Polysaccharides
Bokov Dmitriy O , Maslennikova Maria S, Malinkin Alexei D, Shevyakova Lyudmila V, Bessonov Vladimir V, Nikityuk Dmitriy B
Non-starch polysaccharides (NSP) are polysaccharides that are not able to be digested in the human gastrointestinal tract and are not absorbed into the blood. Despite this, NSP plays an important role in digestion and is used in the food and pharmaceutical industries and has a pronounced biological activity comparable to conventional drugs. Because of this, the development of such drugs and methods for their validation is very urgent and in demand nowadays. In this review, the most interesting and important NSP were considered; their biological effects and their use in the food and pharmaceutical industries were described. Further prospects for the standardization of these compounds are outlined, and ways of further work in this direction are proposed.

2. Design, Development, and Optimization of W/O/W Multiple Nanoemulsion for Anti-Cancer Drug, Gemcitabine Hydrochloride
S Shidhaye, S Tank, B Parab
Purpose: The present study’s objective was to develop, optimize, and evaluate water in oil in water (W/O/W) multiple nanoemulsion of Gemcitabine Hydrochloride for intravenous administration that would protect the drug in the internal aqueous phase thereby preventing its degradation when exposed in plasma. Methods: The microemulsion method was used to prepare initial water in oil (W/O) nanoemulsion. Optimization of primary W/O nanoemulsion was done using 2-factor 3-level full factorial design. Optimized W/O primary emulsion was selected on the basis of particle size data and in-vitro drug release studies. The optimized W/O nanoemulsion was diluted with aqueous phase containing hydrophilic surfactants to get W/O/W multiple nanoemulsion. Results: The optimized W/O/W Multiple emulsion had particle size 132.2nm with 13% drug release in 2hours in phosphate buffer pH 7.4 with 92.09% entrapment of drug within the multiple emulsion system. Conclusion: A novel W/O/W multiple nanoemulsion of gemcitabine hydrochloride was successfully developed to meet the desired objectives of intravenous administration of drug with enhanced enzymatic stability in plasma.

3. Development, Comparison, and Evaluation of Regulatory Models for Quality by Design Based on ICH Guidelines and Indian Guidelines along with Recommendations
Dipan Roy, Roop N Gupta
Quality by Design (QbD) is a flexible approach that helps to build up the quality of a product. Generally, the quality guidelines of International Council for Harmonisation (ICH) are considered for the quality by design (QbD). The ICH Q8 guidelines “Pharmaceutical Development”, ICH Q9 guidelines “Quality Risk Management”, ICH Q10 “Pharmaceutical Quality System”, ICH Q11 “Manufacturing of drug substances” are generally followed to perform a successful QbD. Here we proposed the probable models for QbD according to the ICH guidelines and Indian guidelines and evaluated them along with a comparison study to find out the probable elements for QbD from Indian guidelines. Besides this, the work also finds out the deficiencies of considered Indian guidelines and suggests probable recommendations to improve the guidelines to develop the QbD guidelines as per Indian aspects.

4. Estimation of Atorvastatin Calcium and Vinpocetine in a Pharmaceutical Dosage form using Validated Simultaneous UV Spectroscopic and HPLC Methods
Rita R. Lala, Amol S Shinde
The study aims to validate the Simultaneous equation (SE) method by UV spectroscopic method and by high-performance liquid chromatography (HPLC) method for the atorvastatin calcium (ATS) and vinpocetine (VIN) pharmaceutical formulations. SE method was developed and absorbance was measured at 246 and 273 nm for ATS and VIN, respectively. ATS and VIN’s linearity range were 2-20 μg/ mL and 1-24 μg/mL, respectively. HPLC method was developed simultaneously to determine the ATS and VIN in tablet as a dosage form. The analysis has been done by using Agilent ZORBAX -C18 (250 X 4.6 mm, 5 um) and mobile phase containing acetonitrile: 0.2% orthophosphoric acid (70:30 v/v) at pH 5 (adjusted with Sodium hydroxide). The 1.0 mL/min flow rate was maintained, and detection was carried out at 238 nm (isosbestic point). The retention time of ATS and VIN was found to be 4.16 and 8.20 minutes, respectively. The calibration curves were linear in the concentration range 20–120 μg/ mL and 5–30 μg/ mL for ATS and VIN, respectively. The recoveries were found in the range by both methods. The proposed methods were validated successfully, which was found to be very precise, specific, and accurate; also suitable for ATS and VIN pharmaceutical tablet dosage form, and any dosage form where these two drugs will be present.

5. Effects of Irbesartan in induced Parkinson’s Disease in Mice
Sarah J. Kamal, Haitham M. Khadhim
Irbesartan (Irb) is an angiotensin receptor blockader (ARBs) and agonist of peroxisome proliferator-activated receptor (PPAR) γ, which owns inhibitory effects of inflammation, oxidation, and apoptosis, manipulation of the renin-angiotensin system results in dawdling nigrostriatal damage. The objective of the study is to explore the neuroprotective effect of Irbesartan on the dopaminergic neurons in the substantia nigra pars compacta (SNpc) in a 1-Methyl-4-phenyl-1, 2, 3, 6-tetrahydropyridine hydrochloride (MPTP) mouse model of Parkinson’s disease (PD). Male mice were kept separately into 5 groups control (normal), model, classical treatment, oleic and Irbesartan group, the control group received N/S intraperitoneally (ip) (10 mL/kg) for 5 days, PD induced by MPTP IP (30 mg/kg) daily for 5 days for the all group except control, then all animal from day 6 to day 21 received a single oral dose of the following: control group and PD induced group (model or MPTP group) N/S (20 mL/kg), oleic acid 0.1 mL, Classical treatment (L-dopa/Carbidopa) [(250/25) mg/kg] and Irb (50 mg/kg) daily for 21 days. The behavioral changes of mice were assessed using a pole-climbing test. The levels of dopamine (DA), DA receptor type 2 (D2 receptors), caspase-3 and malondialdehyde (MDA) in the striatum were assayed with the help of the immunohistochemical method in substantia nigra. The results obtained from pole-climbing time in all test groups which performed each 5 days of the experiment (day 5, 10, 15, and 20) at day 5 revealed there were no significant change in time than model group (p > 0.05), at day 10,15 and 20 there were significant decrement in time for Irb group compared to model group (p < 0.001). The DA receptors and MDA decreased significantly in L-dopa, and Irb groups in compared to model group (p < 0.001), DA level were significantly increased in L-dopa and Irb in compared to model group (p < 0.001), while caspase-3 were significantly reduced in Irb in compared to L-dopa and model groups (p < 0.001). The result demonstrates the neuroprotective effect of Irb in PD’s experimental model, suggesting Irb probably a candidate neuroprotective drug for human PD patients.

6. Development and Validation of RP- HPLC Method for Baricitinib using Quality by Design Approach and its Application to Stability Studies
Mannurkar M M, Hamrapurkar P D
The present paper reports a simple, sensitive, precise, and robust reverse phase high performance liquid chromatography (RP-HPLC) method using quality by design (QbD) approach and has been developed and validated for analysis of baricitinib in bulk drug. Design of experiment (DoE) using a Box Behnken design approach was employed for method development and optimization where the critical method variables like mobile phase pH, gradient time, flow rate, and the interaction effects on the drug response parameters i.e., retention time, NTP, asymmetry factor were evaluated. Method: The optimal chromatographic separation was carried out by gradient elution mode on a ZORBAX ODS 250×4.6mm, 5 um column using ammonium formate buffer (pH 7): acetonitrile (ACN) as mobile phase at 25°C with a flow rate of 1-mL/min and injection volume of 10ul. Quantitation was achieved using UV detection at 251nm on Waters Alliance 2695 system with a PDA detector. Result: The retention time for baricitinib was found to be 8.14 minutes. The calibration curve was linear over a range of 1-3 ug/mL with limit of detection (LoD) and limit of quantitation (LoQ) values found to be 0.1 ug/mL and 0.5 ug/mL, respectively. The percent recovery was found to be within an acceptable limit of 98-102%. Forced degradation studies were carried out under acid, base, oxidative, photolytic, and thermal conditions indicating the well-resolved peak of drug and degradation products. Conclusion: The optimized chromatographic method was validated as per ICH Q2 (R1) guidelines and proved to be accurate, precise, specific, linear, and robust; also, all the parameters were within acceptance criteria. Forced degradation studies showed that the method developed was specific and can be employed for monitoring the stability of Baricitinib.

7. Discernment of Adulterants in Milk Samples from Some Local Dairy Farms of Hyderabad
Syed S. Ghori, Fouzia Tehseen, Qurrath U A Sana
Milk is rich in nutrients like proteins, fats, carbohydrates, vitamins and various minerals important for maintaining health and is regarded as a complete food. It is consumed as it is or may be taken in the form of dairy products. As an agricultural product, milk is extracted from mammals of nonhuman origin. India is the world’s largest producer of milk and skimmed milk powder. However, the adulteration of consumable products such as milk is a common practice in India. The addition of urea, detergent, sugars, Vanaspati and other synthetic chemicals render it unfit for consumption according to the standards that define the quality of milk. In the present study, adulterants were investigated in market milk sold by the local vendors in the vicinity of Hyderabad during the year 2020. Sixty samples (n = 60) from different milk producers and dairy shops were collected and examined. Samples were collected in clean, dry, and sterilized glass bottles. Milk samples were tested for the adulterants like water, glucose, starch, skimmed milk powder, neutralizers, urea, detergents, salt, hydrogen peroxide, formalin using a commercially available Adulteration test kit. The study observed that milk was found adultered with water, skimmed milk powder, starch, glucose, urea, sodium chloride, formalin and neutralizers, proving it unfit for human health.

8. Stability Indicating Analytical Method Development and Validation of Ciprofloxacin By RP-HPLC with Fluorescence Detector
Adichanan R Vishnuraj, Bannimath Gurupadayya, Singaram Kathirvel
Ciprofloxacin is an anti-microbial agent, member of the quinolone class compound with activity was found against gram-positive and negative bacteria as well as wide clinical applicability. A simple and sensitive nanomolar concentration for the quantification of ciprofloxacin (QoC) using reverse phase high-performance liquid chromatography (HPLC) method with fluorescence detection. The method was performed using a C18 column at 40⁰C temperature and 0.1% orthophosphoric acid and methanol with a ratio of 70:30 (v/v). The mobile phase was used for the separation of ciprofloxacin. The wavelength of measurement was set at excitation 278 nm and emission 455nm. The method was developed in a 50 to 250 ng/mL concentration with a correlation coefficient of 0.9918. The limit of detection (LoD) and limit of quantification (LoQ) for ciprofloxacin was found to be 0.3215 ng/mL. and 0.9743 ng/mL respectively. The method was sensitive, stability-indicating, and rapid for nanomolar determination of ciprofloxacin in the pure and pharmaceutical dosage form. The analytical procedure was specific and validated as per the ICH guideline (Q2R1).

9. Development and Validation of Dolutegravir in Bulk and Formulation: An Anti-retroviral Drug using UV-spectroscopy
Thaidala Sriveni, Vanamala Naveen, Vemula S Rupa, Aeruva Renuka, Sunil Porika, M Akiful Haque, Vasudha Bakshi, Narender Boggula
Pharmaceutical analysis plays a vital role in the quality assurance and quality control of bulk drugs. Methods for analyzing drugs in single or multi-component dosage forms can be developed, provided one has knowledge about the nature of the sample, namely, its molecular weight, polarity, ionic character, and the solubility parameter. A simple, rapid, precise, and accurate spectrophotometric method has been developed for quantitative analysis of dolutegravir sodium in tablet formulations. The initial stock solution of dolutegravir sodium was prepared in methanol solvent, and subsequent dilution was done in water. The standard solution of dolutegravir sodium in water showed maximum absorption at wavelength 260 nm. The drug obeyed Beer–Lambert’s law in the concentration range of 5–40 μg/mL with the coefficient of correlation (R2) was 0.9992. The method was validated as per the International Council for Harmonisation (ICH) guidelines. The developed method can be adopted in routine analysis of dolutegravir sodium in bulk or tablet dosage form, and it involves relatively low-cost solvents and no complex extraction techniques. The method can be used to determine the purity of the drug available from various sources.

10. Development of Floating Tablet of Amlodipine Besylate for Bioavailability Improvement in Animal Model
Mahesh H. Kolhe, Ritu M Gilhotra, Govind S Asane
Objective: Floating drug delivery system is developed for Amlodipine Besylate to improve bioavailability in animal models using different combinations of polymer and excipients. Significance: Increased blood plasma concentration of the drug compared to existing marketed tablets of the drug improves efficacy. Methods: Floating tablet formulations of the drug were prepared using combinations of polymer and excipients. Average weight, thickness, disintegration, dissolution, and Assay of formulations containing different composition were carried out. The stable, evaluated optimized formulations were subjected to in vivo drug bioavailability in a rat model. Results: Based on the post-compression parameter, buoyancy lag time, total floating time and cumulative %drug release, the optimized formulations were selected. An optimized formulation containing combination of excipients showed good stability and comparative more plasma concentration of the drug in animal model. Conclusions: Floating tablets of Amlodipine besylate were developed to get optimum tablet properties and drug content. The absorption of amlodipine from formulation resulted in multi fold increase in bioavailability as compared to marketed tablets.

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