Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF PERINDOPRIL ERBUMINE AND AMLODIPINE BESYLATE IN TABLET DOSAGE FORM

K. Swetha*, K. Shilpa, A. Ajitha, Dr. V. Uma Maheswara Rao.

Abstract

An isocratic separation was carried out using X-Terra (4.6 ×150mm, 5μm particle size) column and Methanol: Acetonitrile: Water (50:35:15%v/v) as mobile phase with quantification carried out at a wavelength of 215nm. The retention time of the Perindopril erbumine, Amlodipine besylate was 3.234, 1.694 minutes, respectively with theoretical plate count and asymmetry as per the ICH limits. The % assay of Perindopril erbumine and Amlodipine besylate were 99.5% and 98.99%.The flow rate was found to be 1ml/min. The linear regression analysis data for the calibration plots showed a good linear relationship for Perindopril erbumine and Amlodipine besylate over a concentration range of 5-25μg/ml and 6.25-31.25 with correlation coefficient of 0.999 for Perindopril erbumine and 0.999 for Amlodipine besylate. The limits of detection and quantitation were found to be 1.08, 0.80 and 3.27, 2.45 μg/ml respectively.

Keywords: Perindopril erbumine, Amlodipine besylate, PDA Detector; RP-HPLC; Tablet Dosage forms.