Abstract
Astability indicating analytical method was developed for the estimation of isomers content of Darunavir drug substance. The chromatographic separation was achieved on Chiral PAK AD-H which is amylose tris-(3,5-dimethylphenylcarbamate) phase coated on silica matrix. The separation achieved employing a Mobile phase consists of n-Hexane, Ethanol and n-Butanol in the ratio of 83:15:2 (v/v/v) respectively with a flow rate of 0.8 ml/ minute at using an ultra violet detector at 265nm.The average retention times of Isomer-5,Isomer-3,Isomre-4 and Isomer-1 are 29.5 min,37.9 min,51.1 min and 61.9 min respectively.The method was validated with respect to linearity, precision, accuracy, ruggedness, robustness, limit of detection and limit of quantification.
