Development and Validation of HPLC Method for Estimation of Lamivudine in Pharmaceutical formulations

A simple, precise and accurate HPLC method has been developed for the estimation of Lamivudine in pharmaceutical formulations. The chromatographic separation was achieved on Hypersil BDS C18, 150 X 4.6, 5µ analytical column. Mix buffer and acetonitrile used as the mobile phase in the ratio 60: 40 at a flow rate of 1.0 ml/min and detector wavelength at 274 nm. The validation of the method was accomplished for specificity, linearity, accuracy, precision; limit of detection (LOD), limit of quantification (LOQ) and robustness. The linear dynamic ranges were from 3.75–22.50µg/ml for Lamivudine. The percentage recovery obtained for Lamivudine was 98 to 102%. Limit of detection and quantification for Lamivudine was 0.477 and 1.4454 µg/ml. The method was validated for accuracy, precision, robustness, detection and quantification limits as for ICH guidelines. The wide linearity range, accuracy, sensitivity, short retention time and composition of the mobile phase indicate that this method was successfully applied to quantification of Lamivudine in pharmaceutical formulations.