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Abstract

Present research work aimed to develop a High-Performance Liquid Chromatography method for the estimation of selected antiviral agents like abacavir, dolutegravir and lamivudine in bulk and its formulation. Ascentis C18 150 x 4.6 mm, 3.7m column was used. Photodiode array detector was used to detect the analytes. Mobile phase containing Water: Methanol (60:40) was pumped at a flow rate of 0.8 ml/min was selected. The retention time of abacavir, dolutegravir and lamivudine were 2.112 min, 2.545 min and 3.254 min. The linearity was obtained from 75-450µg/ml for abacavir, 6.25-37.5µg/ml for dolutegravir and 37.5-225 µg/ml for lamivudine. Precision studies were carried, and the % RSD was found to be less than 2% for three drugs. The percentage of drug recovery was good with the developed method. The developed method was statistically validated according to the International Council on Harmonization guidelines. All the validation parameters were performed, and the results were present within the acceptance limit. The stability-indicating studies were conducted under various stress conditions. Degradants did not interfere with the retention time of the analyte and were present within acceptance criteria. The current method was economical and rapid when compared to past reported works.

Keywords

Abacavir Dolutegravir Lamivudine ICH guidelines Mobile phase Retention time

Article Details

How to Cite
Anil Vikas Yamana, & Chandra Sekhar Kothapalli Bonnoth. (2020). Simultaneous stability indicating HPLC method development and validation for the estimation of selected antiviral agents in bulk and Pharmaceutical Formulation. International Journal of Research in Pharmaceutical Sciences, 11(4), 5179-5186. https://doi.org/10.26452/ijrps.v11i4.3123