Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF SAROGLITAZAR IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Nita Yadav* and Anju Goyal

Abstract

A simple, sensitive and rapid reverse phase high performance liquid chromatographic method was developed for the estimation of Saroglitazar in tablet dosage form. A C18 Inertsil ODS column (250 × 4.6 mm, 5μm particle size) was used as a stationary phase with a mobile phase containing a mixture of phosphate buffer and acetonitrile in the ratio of 40:60, v/v. The flow rate was 1.0 mL/min. The effluent was monitored at 294 nm and eluted at 2.162 min. Calibration curve was plotted with a range from 20-100 μg/ml for Saroglitazar and the correlation was found to be 0.999. The accuracy range was found between 99.95 -101.07%. The % RSD values for both intraday and interday precision were less than 2.0. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 1.405μg/ml and 4.260μg/ml respectively. The assay was validated for the parameters like system suitability, precision, accuracy, and robustness parameters. The proposed method can be useful for the routine determination of Saroglitazar in pharmaceutical dosage form.

Keywords: Saroglitazar, Calibration curve, RP-HPLC, Validation, ICH guidelines.