Estimation of Saquinavir Mesylate in Tablet Dosage Form using RP-HPLC

Abstract

A simple, precise, rapid and accurate reverse phase HPLC method developed for the estimation of saquinavir mesylate in tablet dosage form. A Sun Fire C18, 250 mm × 4.6 mm i.d, 5 μm partical size, with mobile phase consisting of acetonitrile and 0.03 M potassium dihydrogen phosphate (pH adjusted to 3.2 with orthophosphoric acid) in the ratio of 50:50 v/v was used. The flow rate was 1 mL/min and the effluents were monitored at 235 nm. The retention time was 3.98 min. The detector response was linear in the concentration of 20-240 mcg/mL. The respective linear regression equation being Y= 26704.6X + 84052.1. The limit of detection and limit of quantification was 0.004 and 0.012 mcg/mL, respectively. The percentage assay of saquinavir mesylate was 99.87 %. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of saquinavir mesylate in bulk drug and in its pharmaceutical dosage form.