QUALITY BY DESIGN APPROACH TO STABILITY-INDICATING REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT, OPTIMIZATION, AND VALIDATION FOR THE ESTIMATION OF SIMEPREVIR IN BULK DRUG:

Objective: A simple, robust, precise, and selective stability-indicating liquid chromatography (LC) method (reverse-phase high-performance LC) was developed for the estimation of simeprevir through quality by design paradigm. Methods: The chromatographic separation was performed on Water’s 2695(Alliance) equipped with a photodiode array detector at 300 nm. The method was developed on Discovery C18 column (250×4.6, 5 mm) using orthophosphoric acid and acetonitrile (55:45 % v/v) with the flow rate of 1 ml/min at 30°C. The degradation studies of simeprevir were carried out under the stress conditions of hydrolysis (acid, base, and neutral), oxidation, photolytic, and thermal as per the International Conference on Harmonization (ICH) guidelines. The peroxide hydrolysis shows more critical impurities which were well resolved from pure drug with the application of design of experiment and optimized the method. Results: Independent variables (critical analytical attributes) selected for the method optimization were mobile phase ratio, flow rate, and temperature of the column based on the risk assessment. The retention time and resolution were selected as the method response. In response surface method, the central composite design and 23 factorial designs were employed for the optimization of the method. The polynomial equation was derived for the estimation of method response. Conclusion: The method was optimized for better resolution among the drug, and impurity peaks were then validated as per the ICH parameters

PROTECTIVE EFFECT OF ETHANOLIC ROOT EXTRACT OF COMMIPHORA CAUDATA AGAINST DIABETIC-INDUCED RATS IN HIGH-FAT DIET-STREPTOZOTOCIN MODEL

Objective: The present study was to explore the phytochemical analysis and antidiabetic potential of the root of Commiphora caudata in high-fat diet (HFD) streptozotocin-induced diabetic rats. Methods: The ethanolic root extract of C. caudata at a dose of 400 mg/kg and 200 mg/kg was administered to diabetic rats. Glibenclamide (5 mg/kg) was used as standard drug. Results: The data were statistically assessed using one-way ANOVA followed by Dennett’s multiple comparison tests. To unfold the mechanism, we studied all the biochemical parameters glucose, total cholesterol, triglycerides (TG), high-density lipoproteins (HDL), low-density lipoproteins (LDL), and very LDL (VLDL) and histopathological examination of the pancreatic tissue section. The ethanolic extracts of root of C. caudata showed significant reduce of the level of cholesterol, TG, LDL, VLDL, and significant increase in the serum level of HDL at 400 mg/kg rather than 200 mg/kg. Conclusion: Further studies should look into the characterization and isolation of the constituents to know the exact mechanism of hypoglycemic activity. Statistical analyses of this screening method confirm that the proposed method is appropriate and it can be expected to improve basic idea to the researcher who is working in area-like antidiabetic activity

Validating alcohol use measures among male drinkers in Goa: implications for research on alcohol, sexual risk, and HIV in India.

Assessment of heavy drinking patterns is vital for HIV/AIDs studies in India and developing countries. A population survey in northern Goa included urban and rural male drinkers (n = 743) who completed a new Fractional Graduated Frequencies (F-GF) alcohol patterns measure assessing seven beverage types and drink sizes for the largest daily amount, then drinking frequencies at fractional amounts. The new measure was compared to a simpler quantity-frequency (QF) summary and, in a validity subsample of hazardous drinkers (n = 56), 28-day diaries of drinking events. Approximately 56% of total volume came from peak drinking (averaging 60 g ethanol/day). For AUDIT-based Hazardous Drinkers, QF and F-GF volumes (drinks/day) were not significantly different from diary volume (correlations 0.65 and 0.57, respectively). F-GF well captured the profile of daily amounts in drinking event data. In addition, the F-GF showed evidence of better predicting any sexual risk behavior or partner violence perpetration than the QF measure. Summary drinking pattern measures, especially the new F-GF, are more cost efficient than intensive event records, and appear valid when carefully assessing quantities with local beverage types and drink ethanol content