Development and Validation of HPLC Method for the Estimation of Anti-HIV Drug Abacavir Sulphate in Bulk and Pharmaceutical Formulations.

Abstract

Objective: Analytical method development and validation was useful for estimation of drugs in bulk and biological fluids. They help to improve the reliability, consistency and accuracy of analytical data. Present investigation involves development and validation of RP-HPLC chromatographic method for abacavir sulphate as per ICH guidelines.   Methods: The present work describes method development and validation by reverse phase high performance liquid chromatographic method for estimation of abacavir sulphate in bulk and pharmaceutical dosage forms. RP-HPL Chromatography method development and validation was performed on a hypersil stainless steel C₁₈ column of 25 x 4.6 mm packed with octadecylsilane silica packing 5µm particle size with ammonium dihydrogen orthophosphate buffer and methanol (40:60) adjusted to pH to 6.0 at a flow rate of 1.0 ml/min with 20 min runtime, a wavelength of 214 nm, column oven temperature 27ºC with 20µl injection volume.

Results: In this current study, The UV detector showed absorption maxima 249 nm and correlation coefficient of 0.99939. The selected RP-HPL chromatographic conditions exhibited 3.85 min retention time for abacavir sulphate and linearity was found in the range of 0-150 μg/ml. The proposed RP-HPLC method was found to be economic, accurate, precise, and reproducible. It could be used for analysis of abacavir sulphate in bulk and pharmaceutical formulations.                 Conclusion: Developed analytical method for abacavir sulphate was sensitive and reproducible for estimation of drug candidate in day to day regular analysis and the results obtained in this study were accurate within low standard deviation values. The developed analytical method by RP-HPLC would help for sensitive analysis of abacavir sulphate in bulk and formulations.

KEYWORDS: Abacavir sulphate, RP-HPLC, Method development, Validation.