Abstract

A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF ABACAVIR, LAMIVUDINE AND DOLUTEGRAVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

N. Khaleel* and Sk. Abdul Rahaman

Abstract

A new simple, precise, selective, accurate and rapid reverse phase high performance liquid chromatographic stability indicating method had been developed and validated for simultaneous quantitative determination of Abacavir, Lamivudine and Dolutegravir in bulk and pharmaceutical dosage form. The chromatographic separation was achieved with Inertsil ODS 250×4.6 mm, 5μm particle size column. The optimized mobile phase consisting of pH 3.0 Phosphate buffer: Acetonitrile: Methanol (50:20:30 %v/v). The flow rate was 1.0 mL/min and eluents were detected at 257 nm using PDA detector. The retention time of Lamivudine, Abacavir and Dolutegravir were found to be 2.169, 2.676 and 6.367 respectively. The percentage recoveries for Lamivudine, Abacavir and Dolutegravir were found to be in the range of 98.01 -101.5 %, 99.20 – 101.67 % and 98.35 - 102.14 %. The calibration curve was constructed between peak area vs concentration and demonstrated good linear in the range of 15 -90 μg/ml for Lamivudine, 30-180 μg/ml for Abacavir and 2.5-15 μg/ml for Dolutegravir. Degradation studies were studied for Abacavir, Lamivudine and Dolutegravir under various stress conditions such as acid hydrolysis, base hydrolysis, oxidation, thermal, photochemical and UV. All the degradation peaks were resolved effectively using developed method with different retention times. The developed method was validated according to ICH guidelines. As the method could effectively separates the degradation products from active ingredient, it can be used for routine analysis of drug both in bulk and pharmaceutical dosage form.

Keywords: Abacavir, Lamivudine and Dolutegravir, Methanol, Acetonitrile, Buffer, RP-HPLC.