RP-HPLC Estimation of Nelfinavir Mesylate in Bulk Drug and Pharmaceutical Formulation

Abstract

A simple, rapid and reproducible high performance reversed phase liquid chromatographic method has been developed for the estimation of nelfinavir in bulk drug sample and pharmaceutical dosage forms using kromosil C₁₈ column. The mobile phase consists of potassium dihydrogen phosphate and acetonitrile in the ratio of 30:70 v/v, respectively and was pumped at rate of 1.3 mL/min at 25 °C. The detection was carried out at 220 nm and the calibration curve was linear in the range of 5 to 30 μg/mL. The method was statistically validated for its linearity, precision and accuracy. The intra-day and inter-day variation was found to be less than 1 % showing high precision of the assay method. Due to its simplicity, rapidness, high precision and accuracy, the proposed RP-HPLC method may be used for determining nelfinavir mesylate in bulk drug sample or in pharmaceutical formulations.