Abstract

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

B.Siddartha*, Dr. I. Sudheer Babu

ABSTRACT

A simple, sensitive and rapid reverse phase high performance liquid chromatographic method was developed for the estimation of Saroglitazar in pure and pharmaceutical dosage forms. A Kromasil C18 column (150 x 4.6mm x 5μm) was used as a stationary phase with a mobile phase containing a mixture of buffer (1ml of ortho phosphoric acid was diluted to 1000ml with water) and acetonitrile in the ratio of 35:65v/v. The flow rate was 1.0ml/min. The effluent was monitored at 295nm and eluted at 3.099min. Calibration curve was plotted with a range from 10-60μg/ml for Saroglitazar and the correlation was found to be 0.9997.The accuracy range was found between 98.87% and 101.45%. 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 0.716μg/ml and 2.169μg/ml respectively. The assay was validated for the parameters like specificity, system suitability, precision, accuracy, robustness and ruggedness parameters. The proposed method can be useful for the routine determination of Saroglitazar in pharmaceutical dosage form.

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