4^th European Congress on
Pharmaceutical Sciences

Biography:

S Angala parameswari has expertise in Analytical method development and validation and passion in improving interpretation of analytical data. She has 12 years of experience in research, evaluation, teaching and guidance of students in education institutions. She honoured as Best teacher in 2015 by AKSHARA KEERTHI PATTABHADRULA SAMKSHEMA SEVA SAMITHI, Nellore. She has published 25 above research publication and attended 15 above conferences national and international levels. She has guided 44 PG students and 25 UG student and 4 Ph.D students during her professional life. She was a life member in APTI.

 

Abstract:

A simple, accurate & precise method was developed for the simultaneous estimation of Darunavir (DAR), Cobicistat (COB), Emtricitabine (EMT) and Tenofovir alafenamide (TEN) in their bulk and pharmaceutical formulation. Combination of DAR, COB, EMT and TEN is a first ever protease-inhibitor-based single-tablet regimen with DAR being a Protease Inhibitor(PI), COB a pharmacokinetic enhancer of DAR and EMT, TEN belonging to Nucleoside reverse transcriptase inhibitors (NRTI) is recently approved by U.S. Food & Drug Administration (US FDA, 2018) and European Medical Agency (EMEA, 2018). Literature review has revealed that no analytical method has been published. This study also deals with stability studies for developing a degradation pathway and to isolate the impurities which are likely to be present. Chromatogram was run through Agilent C₁₈ (150 x 4.6 mm, 5m) column. Mobile phase containing 0.1% Ortho Phosphoric acid (OPA) (pH 2.4) and Acetonitrile in the ratio of 55:45 was pumped through the column at a flow rate of 0.75ml/min while the temperature was maintained at 30°C. The optimized wavelength for the combination was 245 nm. Retention time of DAR, COB, EMT, and TEN were found to be 3.988 min, 3.147 min, 2.205 min and 2.616min respectively. The linearity range for the method was found to be 200-1200µg/ml for DAR, 37.5-225 µg/ml for COB, 50-300 µg/ml for EMT and 2.5-15 µg/ml for TEN. The method was validated according to ICH guidelines. Forced Degradation studies were performed on different conditions and the % drug degraded was found to be within limits.  Conclusion: The developed and validated method can be routinely used for the analysis of pharmaceutical formulation.