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Abstract

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

Rucha V. Pancham*, Dr. Milind J. Umekar and R. T. Lohiya

ABSTRACT

An Stability indicating high performance liquid chromatographic (RP-HPLC) method was developed for the determination of Saroglitazar in bulk and pharmaceutical dosage form. The SHIMADZU HPLC system equipped with UV Visible detector, ACE 3C18-AR- HPLC Column (80×4.6mm) column and a mobile phase of mixture of disodium hydrogen phosphate buffer and acetonitrile in a ratio of 58:42 v/v at a flow rate of 1.mL/min were adopted for the separation. software was used for data handling. About 20μL of working standard solution of concentration 20μg/mL was injected into the column, and the component was separated by carrying out elution for a run time of 10 minutes and the component was retained at column for 3.141 minutes and wavelength was detected at 295 nm. Repeatability, reproducibility, robustness, ruggedness and linearity of the developed method were determined. Linearity (4-24μg/mL), correlation coefficient (1), were evaluated. The stress stability study have being reported, including solution state analysis and solid state analysis. 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.

Keywords: Saroglitazar, HPLC, Validation, Stress Stability Study.


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