Abstract

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

Vallampati Surendra, K. Thejomoorthy*, CH. Saibabu

ABSTRACT

A simple, precise, rapid and reproducible stability indicating RP - HPLC method was developed and validated for the estimation of Saroglitazar in pharmaceutical dosage forms. Chromatography was performed 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. The detection was carried out at 292 nm using analytical Tech. PDA 996 Detector. The obtained calibration curve was linear in the concentration range of 10-50μg/ml. The limit of detection and quantification was found to be 1.81 g/ml and 5.5 g/ml respectively. It was found that the amount of Saroglitazar present inthe Tablet formulation was 100%. The method was validated statistically using SD, %RSD and SE and the values are found to be within the limits. The recovery studies were performed and the percentage recovery was found to be 100 %.

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