Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CILNIDIPINE AND IRBESARTAN IN ITS PHARMACEUTICAL DOSAGE FORM

Prajapati Ketulkumar M.*, Bhumi Patel, Jaymin Patel, Dr. Vinay Darji, Jatinkumar D. Raja

ABSTRACT

A simple, rapid, precise and accurate Stability indicating Reverse Phase High Performance Liquid Chromatography (RP-HPLC) Method For Simultaneous Estimation of Irbesartan and Cilnidipine in their combined dosage form has been developed. The RP-HPLC method was developed for the simultaneous Estimation of Irbesartan and Cilnidipine in their combined dosage form development method has been achieved. The separation was attained by Column C18 (25 cm × 0.46 cm) Hypersil BDS and Buffer (pH 5.5): Acetonitrile (40:60 v/v) (Flow rate-1.0 ml/min) as mobile phase at a flow rate 1ml per minute, Detection was carried out of wavelength of 240 nm retention time of irbesartan and cilnidipine were found to be 3.730 and 6.040 min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for range of 1-3μg/mL for cilnidipine and 30-90μg/mL for irbesartan. The percentage recovery obtained for cilnidipine and irbesartan were found to be in range 100.61 ± 0.46, 100.68 ± 0.80 respectively. Development method was found to be accurate, Precise and rapid for simultaneous estimation of Irbesartan and Cilnidipine in their combined dosage form.

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