Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF IRBESARTAN, AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE IN TABLET

*Acharya Vidhi M.

Abstract

The simple, specific, accurate & precise RP-HPLC method have been developed and validated for simultaneous estimation of triple dose combination which is used to treat hypertension. The triple combination is of Hydrochlorothiazide, Amlodipine besylate and Irbesartan. In this method the chromatographic system was equipped with Phenomenax C18 column (25cm x 0.46 cm, 5μ) as stationary phase and UV detector set at 224 nm, in conjunction with a mobile phase of Phosphate Buffer(pH 4.5): Acetonitrile in theration of 55:45% v/v ratio at a flow rate of 1.0ml/min. the retention time of Hydrochlorothiazide was 3.489 min, for Amlodipine besylate it was 4.181 min & the retention time of Irbesartan was 11.376 min. This method was linear with correlation coefficient 0.9970, 0.9974 & 0.9973 respectively. Also there was no any interference of diluent with chromatogram of standard & sample. The % recovery were 99.37, 100.70 & 100.28%. Also it was statistically validated for accuracy, precision, specificity & robustness as per ICH guidelines. After analyzing the data of validation, we can say that this method can be used for further analysis. As this proposed method is rapid, specific, accurate, and robust with good resolution & short run time. So, the method can be used for routine analysis.

Keywords: Hydrochlorothiazide, Amlodipine besylate & Irbesartan, simultaneous RPHPLC, Method validation.