Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STUDIES FOR THE ESTIMATION OF ABACAVIR AND LAMIVUDINE IN BULK AND FIXED DOSE COMBINATION (TABLETS) BY RP-HPLC

*M. Gayathri Devi, W. A. Umarani and Dr. G. Sudhakara Rao

ABSTRACT

A new RP-HPLC method for the quantitative determination of Abacavir and Lamivudine was developed and validated as per ICH guidelines. The drugs were injected into inertsil ODS C18 column (150×4.6, 5 m), maintained at ambient temperature and effluent monitored at 228 nm. The mobile phase consisted of phosphate buffer: acetonitrile [HPLC grade] (70: 30V/V). The flow rate was maintained at 1.0 mL/min. The developed method shows high specificity forAbacavir and Lamivudine. The calibration curve for Abacavir and Lamivudine were linear from 10-60 μg/ml and 5-30 μg/ml respectively (r2 for Abacavir =0.998, r2 for Lamivudine =0.998).The proposed method was adequate, sensitive, reproducible and specific for the determination of Abacavir and Lamivudine in bulk and pharmaceutical dosage froms.

Keywords: Abacavir and Lamivudine.