Development and Validation of RP – HPLC Method for Estimation of Lamivudine and Dolutegravir Sodium in Synthetic Mixture

Abstract

The present study was aimed to develop and validate simple, sensitive, precise, economic and accurate method for simultaneous estimation of Lamivudine and Dolutegravir Sodium in synthetic mixture. The RP-HPLC was performed using Intersil C18 column (150mm*3mm, 3μm particle size), a binary mixture of methanol and water at a flow rate of 1.0 ml/min. Both the drugs were analysed at 260 nm using PDA Detector. The Lamivudine and Dolutegravir Sodium show linearity in the range of 7.5–45 μg/ml and 1.3–7.8 μg/ml respectively. The retention times of Lamivudine and Dolutegravir Sodium were found to be 2.870 min and 5.637 min respectively. The developed method was evaluated for precision, accuracy and robustness parameters also. The intraday and inter day precision data found to be less than 2% RSD showing the method is precise. The accuracy study was performed using standard addition technique and found between 98–102%. The Limit of Detection was found to be 2.10 μg/ml and 0.37 μg/ml for Lamivudine and Dolutegravir Sodium respectively. The limit of Quantitation was found to be 6.38 μg/ml and 1.14 μg/ml for Lamivudine and Dolutegravir Sodium respectively. The % RSD for robustness study was also found below 2%, indicates that the method is robust.