Analytical Method Development and Validation of Anti-HIV Drug Abacavir Sulphate.

ABSTRACT

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 UV spectroscopic method for abacavir sulphate as per ICH guidelines. The present work describes sensitive and robust method development of abacavir sulphate by UV spectroscopic method for estimation of abacavir sulphate in bulk and pharmaceutical dosage forms using UV-1700 pharma spec (Shimadzu). The method was validated for accuracy, precision, linearity, ruggedness and robustness to check its consistency. The wavelength scan of UV spectroscopic method showed absorption maxima 249 nm obeying beers law with linearity range of 0-40μg/ml and correlation coefficient of 0.99939. Molar absorptivity and sandell’s sensitivity are found to be 1.2404472 ×10-4 and 0.0208 respectively. The accuracy was found to be 99.94%-100.2% with recovery 99.76%, 100.06%, 100.07% for 50%, 100%, 150% solutions. The obtained results indicated that the developed analytical method was sensitive, accurate, with low standard deviation values for all validation parameters and could be used in day to day regular analysis of abacavir sulphate in bulk and pharmaceutical formulations.