Stability indicating Method development and Validation of Lamivudine, Zidovudine and Nevirapinein Tablet dosage form

Abstract

The RP-HPLC method for Lamivudine, Zidovudine and Nevirapine was developed using Inertsil ODS 3V C18 column (5µm, 150mm × 4.6mm) as stationary phase and 0.01M 1-octane Sulphonic acid: Methanol (60:40v/v, pH2.6) as mobile phase. The mobile phase was maintained at a flow rate of 1ml/min, run time 15 min and detection was carried out at 270nm.Lamivudine, Zidovudine and Nevirapine were found to be linear in the concentration range of 75-225µg/ml, 150-450µg/ml and 100-300µg/ml respectively. The result of % assay of marketed formulation was found as 101.93±0.1527, 100.86±0.2021and 94.2±0.1527 for Lamivudine, Zidovudine and Nevirapine respectively. Accuracy of the method was determined by performing recovery study and the result were found in the range of 100.9-101.4%, 100.1-100.7% and 99.0-99.9% for Lamivudine, Zidovudine and Nevirapine respectively. Percentage RSD of precision study of these drugs were found less than 2 percent which indicated good precision of the developed method. The proposed method was validated for linearity, accuracy, precision, and robustness. The proposed method is simple, rapid. precise and reproducible hence can be applied for routine quality control analysis of Lamivudine, Zidovudine and Nevirapine in pharmaceutical dosage form.