Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING STUDY OF OLMESARTAN MEDOXOMIL IN TABLET DOSAGE FORM BY REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Sapana Jain*, Vaishali Jadhav, Ashish Jain, Harshada Khude, Shraddha Kachare, Priyanka Halse

Abstract

The purpose of stability testing is to provide evidence on how quality of drug substance varies under influence of temperature, humidity and light. Forced degradation is carried out to demonstrate as specificity which can help identify the likely degradation products. In the current study we have developed analytical method for Olmesartan Medoxomil in tablet dosage form. The studies were carried on Shimadzu HPLC system LC 2010, using Inertsil ODS, C18 Column, 150cm, 4.6mm, particle size 4μm. The wavelength selected was 257nm. The flow rate was 1ml/min. The mobile phase selected after optimization was ACN: Buffer (50:50). The regression coefficient of correlation was 0.9917. % RSD values reported were less than 2 all through validation which indicates variation in results are minimal. The forced degradation studies were conducted, and the least degradation was found in thermal condition. The method is quite simple, rapid and economical in terms of time taken and amount of solvents used. The stability indicating method was validated according to present ICH guidelines for specificity, linearity, precision and robustness.

Keywords: Olmesartan Medoxomil, HPLC, validation, stability, ICH.