Abstract

RP-HPLC METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDIES FOR ESTIMATION OF IRBESARTAN IN PHARMACEUTICAL DOSAGE FORM

Pawar A. R.* and Mirpagar A. R.

ABSTRACT

A simple, rapid, precise and accurate Stability indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) Method For Estimation of Irbesartan in dosage form has been developed. The RP-HPLC method was developed for the Estimation of Irbesartan in their dosage form development method has been achieved. The separation was attained by Column C18 (25 cm×0.46 cm) Hypersil BDS and Buffer (pH 6) Methanol: Water (85:15) found to be 6.040 min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for range of 1-3μg/mL for and 30-90μg/mL for irbesartan. The percentage recovery obtained for irbesartan were found to be in range 100.68 ± 0.80. Development method was found to be accurate, Precise and rapid for simultaneous estimation of Irbesartan in their combined dosage form.

Keywords: Irbesartan, Stability indicating RP-HPLC Method, Validation.