Monday , 27 May 2024

Stability Indicating RP-HPLC Method for Simultaneous Estimation of Amlodipine and Benazepril In Bulk and Pharmaceutical Dosage Form

Mannepalli Mounika, V. Haribaskar*, B. Prathap, Ramesh Dhani
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore

 A B S T R A C T
A simple, Accurate, rapid and precise method was developed for the simultaneous estimation of the Amlodipine and Benazepril in Tablet dosage form. The chromatogram was run through Inertsil ODS (4.6 x 100mm, 5µm). Mobile phase containing0.1%TEA: Methanol: Acetonitrile is taken in the ratio 40:30: 30 was pumped through the column at a flow rate of 1 ml/min. The buffer used in this method was 0.1%TEA buffer. The temperature was maintained at 25°C. Optimized wavelength selected was 235 nm. The retention time of Amlodipine and Benazepril were found to 2.41 min and 3.31. % RSD of Amlodipine and Benazepril were found to be 0.3 and 0.7 respectively. % Recovery was obtained at 100.6% and 99.9% for Amlodipine and Benazepril respectively. LOD, LOQ values obtained from regression equations of Amlodipine and Benazepril were 3.30, 10.02 and 2.98, 9.98 respectively. The accuracy and reliability of the method were assessed by evaluation of linearity, precision (intra-day and inter-day % RSD >2 for Amlodipine and Benazepril), accuracy and specificity, in accordance with ICH guidelines. This method has been successively applied to the pharmaceutical formulation and was validated according to ICH guidelines.

Keywords: Amlodipine, Benazepril, RP-HPLC

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