Abstract

DEVLOPMENT AND VALIDATION OF UV-SPECTROSCOPY AND RP-HPLC FOR SIMULTANEOUS ESTIMATION OF ABACAVIR SULPHATE AND LAMIVUDINE IN TABLET DOSAGE FORM.

Jyoti Patel*, S. T. Patil and S. P. Pawar

Abstract

The mechanism of the RP:HPLC is the retention by the interaction of non-polar hydrocarbon chain of stationary phase with non-polar parts of the sample molecules. This method has been developed for simultaneous determination of antiretroviral drugs which are widely used such as, Abacavir Sulphate and Lamivudine in Tablet dosage form and was carried on column C18(grace) (150×4.6, 5μm) with UV detection at 228 nm using a mobile phase composition of methanol and water (15:85)at a flow rate of 1ml/min. The proposed method was validated in terms of linearity, accuracy, precision, robustness, ruggedness, specificity, limit of detection and limit of quantification as per ICH and USP guidelines and it found suitable for the routine quality control analysis of the drugs in tablet dosage forms. Linearity of abacavir and lamivudine were found in the range of 10-50g/ml and 5-25 g/ml respectively. The limit of detection was found to be 0.598 and 0.598 for abacavir and lamivudine respectively. Limit of quantification was found to be 8.163g/ml and 1.814 g/ml for abacavir and lamivudine respectively. Hence, it was concluded, chromatographic method developed for abacavir sulphate and lamivudine said to be rapid, simple, specific, sensitive, precise, accurate and reliable that can be effectively applied for routine analysis in research institutions, quality control department in industries, approved testing laboratories, bio-pharmaceutics and bioequivalence studies and in clinical pharmacokinetic studies.

Keywords: Antiretroviral agents, Abacavir Sulphate, Lamivudine, RP-HPLC.