Novel Stability-Indicating RP-LC Method for the Determination of Nelfinavir Mesylate and its Related Impurities in Drug Substance and Pharmaceutical Formulations

摘要

A simple, isocratic liquid chromatographic method was developed for determination of nelfinavir from its impurities, degradation products, and assay for the first time. This method involves the usage of a C_(18) (Hypersil BDS C_(18), 250 mm x 4.6 mm, 5mum) column. The method was validated over the range of LOQ to 120% of impurity specification limit and LOQ to 150% of analyte concentration for assay. The mobile phase consists of the mixture of 50 mM of sodium phosphate buffer, acetonitrile, and methanol in the ratio of 30:50:20. The flow rate was set at l.0mL/min with UV detection monitored at 220 nm. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal degradation. The developed method was validated for linearity, range, precision, accuracy, and specificity.