Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SAROGLITAZAR IN BULK AND TABLET DOSAGE FORM

P. Sripriya*, G. Naga Sowjanya, A. Ajitha, and V. Uma Maheswara Rao

Abstract

A simple, precise, rapid and reproducible stability indicating RP -HPLC method was developed and validated for the determination ofSaroglitazar in pharmaceutical dosage forms. Chromatography wasperformed on a ODS C18 (ODS) column (250 mm X 4.6 mm i.d.Particle size 5) Acetonitrile: Triethylamine buffer pH4.6:Methanol(70:20:10 v/v) as a mobile phase at a flow rate of 1 ml/ min. Thedetection was carried out at 292 nm using analytical Tech. PDA 996Detector. The obtained calibration curve was linear in theconcentration range of 10-50μg/ml. The limit of detection andquantification was found to be 1.81 g/ml and 5.5 g/ml respectively.It was found that the amount of Saroglitazar present in the Tabletformulation was 100%. The method was validated statistically usingSD, %RSD and SE and the values arefound to be within the limits. The recovery studies were performed and the percentagerecovery was found to be 100 %.

Keywords: Saroglitazar, RP-HPLC, PDA detection, Isocratic Elution;Tablet dosage forms.