Research Journal of Science and Technology

  • Year: 2020
  • Volume: 12
  • Issue: 3

Simultaneous method development and Validation of Amlodipine and Valsartan by HPLC

Department of Pharmaceutical Analysis, Krupanidhi College of Pharmacy, Bangalore-560035

Abstract

The present work describes a simple, rapid and reproducible reverse phase high performance liquid chromatography also termed as RP-HPLC method for simultaneous estimation of amlodipine and valsartan. C18 column having 150 x 4.6mm diameter was used as stationary phase and a mobile phase containing HPLC grade methanol and water in the ratio of 90; 10 v/v respectively. Orthophosphoric acid used for the pH adjustment to 3.2. The flow rate was 1.0 ml/min and elutes were detected by UV detector at 254nm. The retention time were found to be 1.1 min and 2.1 min for amlodipine and valsartan respectively. The developed method was validated according to the ICH guidelines and found to be linear within the range of 8-28mcg/ml for both drugs. Precision was found to be <2%. The proposed method was successfully used for the simultaneous estimation of amlodipine and valsartan in bulk and formulation. Validation studies revealed that method is specific, rapid and reliable. The % of recovery and less %RSD confirms the suitability of proposed method for routine analysis.

Keywords

Method development, Validation, Amlodipine, Valsartan, ICH guideline, Spectroscopy