A validated rp-hplc method for abacavir sulphate

The objective of this study was to develop a robust, rapid and validated reverse phase liquid chromatographic method for the quantitative determination of related substances of Abacavir sulfate. Reverse phase method was developed and optimized with chromatographic conditions as column of YMC Pack Pro C18, 150 mm x 4.6 mm, 3µ particle size, 0.05% Phosphoric acid in water as mobile phase A and 100% Acetonitrile as mobile phase Column flow fixed as 1.0mL/min in gradient mode. The column temperature was maintained at 45°C. Detection wavelength was set at 220 nm and the injection volume was 10 µL. Water and Acetonitrile in the ratio 90:10(v/v) was used as a diluent. The developed RP-HPLC method was validated according to ICH guidelines. In this method the LOD and LOQ values for abacavir and all its related impurities were ranged from 0.004µg/mL to 0.013µg/mL and 0.023 µg/mL to 0.076 µg/mL respectively. The percentage recovery for all impurities was ranged from 92 to 112 % w/w. The test solution and mobile phase were observed to be stable up to 48 h after preparation. The validated method produced good results of precision, linearity, accuracy, robustness and ruggedness. The proposed method was found to be suitable precise, sensitive and accurate for the quantitative determination of related impurities in the bulk samples of abacavir sulfate API (1)(2).