Abstract
An isocratic reverse phase stability indicating high performance liquid chromatographic (RP-HPLC) method was developed for the determination of Saroglitazar in bulk and pharmaceutical dosage form. The Waters HPLC system equipped with UV Visible detector, Altima ODS C18 (150 mm x 3.9 mm; 5μ) column and a mobile phase of mixture of disodium hydrogen phosphate buffer and acetonitrile in a ratio of 40:60 v/v at a flow rate of 1.2mL/min were adopted for the separation. Empower-2 software was used for data handling. About 20μL of working standard solution of concentration 40μg/mL was injected into the column, and the component was separated by carrying out elution for a run time of 7 minutes and the component was retained at column for 2.827 minutes and wavelength was detected at 294 nm. Repeatability, reproducibility, robustness, ruggedness and linearity of the developed method were determined. Linearity (10-60μg/mL), slope (11373) and intercept (1739.3), correlation coefficient (0.9994), limit of detection (0.13μg/mL) and limit of quantification (0.41μg/mL) were evaluated. The proposed method was readily applied for the assay of pharmaceutical formulations and the results were found to be accepted, therefore the proposed method can be adopted for the routine analysis of any quality control laboratory.
