Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Stability-Indicating HPLC Method for the Simultaneous Determination of Valsartan and Ezetimibe in Pharmaceuticals

Sridevi Ramachandran¹ , Badal Kumar Mandal¹, Sameer G Navalgund²

¹School of Advance Sciences, Vellore Institute of Technology University, Vellore-632041; ²Analytical Research and Development, U.S. Pharmacopeia â€“ India (P) Ltd, IKP, Shameerpet, Hyderabad 500078, India.

For correspondence:- Sridevi Ramachandran Email: sri.metrology@yahoo.in Tel:+919160088330

Received: 16 April 2013 Accepted: 23 March 2014 Published: 23 May 2014

Citation: Ramachandran S, Mandal BK, Navalgund SG. Stability-Indicating HPLC Method for the Simultaneous Determination of Valsartan and Ezetimibe in Pharmaceuticals. Trop J Pharm Res 2014; 13(5):809-817 doi: 10.4314/tjpr.v13i5.23

© 2014 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To develop a simple, accurate, sensitive, precise and robust reverse-phase HPLC stability-indicating method for the simultaneous estimation of valsartan and ezetimibe in combined tablet formulation.

Methods: A stability indicating method for the simultaneous estimation of valsartan and ezetimibe in combined tablet formulation using a RP-HPLC was developed and validated as per ICH guidelines using a symmetry C18 column with a mobile phase comprising phosphate buffer and acetonitrile (58:42 v/v, pH 3.15) with a flow rate of 0.8 mL/min at 230 nm. Stress degradation studies were performed in acidic, alkaline, oxidation and photolysis conditions to demonstrate the stability-indicating power of the method.

Results: The contents of valsartan and ezetimibe were in the range of 99.77 ± 0.10 and 99.30 ± 0.43 % in the marketed formulation, 99.77 ± 0.08 and 99.29 ± 0.38 for the test formulation, respectively. The correlation coefficient for both valsartan and ezetimibe was 0.999 and recovery was in the range of 98 – 102 %. The limit of detection (LOD) was 0.2 and 0.3 µg/mL for valsartan and ezetimibe, respectively, while limit of quantification (LOQ) was 1 µg/mL for both valsartan and ezetimibe, respectively.

Conclusion: The proposed method is simple, precise, accurate, reproducible, specific and reproducible used for the quantitative determination of valsartan and ezetimibe in bulk and dosage formulations.

Keywords: Valsartan, Ezetimibe, Validation, Stability-indicating, Pharmaceuticals