Wed, 22 Nov 2017

Development and Validation of RP- HPLC Method For The Simultaneous Estimation of Amlodipine Besylate and Valsartan In Solid Dosage Form

K. Rahul*, Ch. Devadasu1, P. Srinivasa Babu1

1. Department of Pharmaceutical Analysis and Quality Assurance,  Vignan Pharmacy College, Vadlamudi, Guntur-522213, Andhra Pradesh, India.


ABSTRACT

The objective of the present research work was to simultaneously separate the anti-hypertensive agents, Amlodipine and Valsartan and develop a validated analytical method for simultaneous quantitative determination of amlodipine and valsartan in tablet dosage form. A simple, rapid, precise and selective chromatographic method was developed and validated for separation and determination amlodipine and valsartan in tablet preparations. The anti-hypertensive agents were analyzed by Symmetry C18, (150 × 3.4 mm, 5 µ), Shimadzu LC-2010CHT Prominence Liquid Chromatograph and a mobile phase constituted of 10 mM Buffer (pH 3.0): methanol (50:50, v/v). The flow rate was 1.0 mL/min and the analysis were performed using UV- Vis detector at 237nm. The anti-hypertensive agents, Amlodipine and Valsartan were separated within 10 min. Amlodipine and Valsartan showed retention time of 5.06 and 8.28 min respectively. The drugs were found to obey Beer’s law in the concentration range of 100 ppm of amlodipine and 128 ppm of valsartan. The developed assay method is selective, precise and accurate. The method has been successfully applied for determination of Amlodipine and Valsartan in pharmaceutical combination tablet dosage form. This developed method is sensitive, fast and simple with excellent peak symmetry and high resolution.

Keywords:  Amlodipine, Valsartan, Gradient RP-HPLC, UV detection, Validation.


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