Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Simultaneous Spectrophotometric Determination of Valsartan and Ezetimibe in Pharmaceuticals

Sridevi Ramachandran^1,2 , Badal Kumar Mandal¹, Sameer G Navalgund²

¹School of Advance Sciences, Vellore Institute of Technology University, Vellore Tamil Nadu-632041; ²Analytical Research Department, International Specialty Products (India) Private Limited, 2nd and 3rd Floor Bhupal Towers Somajiguda, Hyderabad Andhra Pradesh - 500082, India.

For correspondence:- Sridevi Ramachandran Email: sridevir@yahoo.com Tel:+9104044747000

Received: 9 March 2011 Accepted: 23 October, 2011 Published: 25 December 2011

Citation: Ramachandran S, Mandal BK, Navalgund SG. Simultaneous Spectrophotometric Determination of Valsartan and Ezetimibe in Pharmaceuticals. Trop J Pharm Res 2011; 10(6):809-815 doi: 10.4314/tjpr.v10i6.15

© 2011 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 direct, simple and extraction-free spectrophotometric method for the simultaneous estimation of valsartan and ezetimibe in pharmaceuticals.

Methods: A spectrophotometric method for the determination of valsartan and ezetimibe was developed using acidic dyes, namely, bromophenol blue (BPB) and bromocresol green (BCG). The method was based on selective ion-pair formation between valsartan and the acidic dye. The yellow coloured ion-pair induces a bathochromic shift in the spectrum with maximum absorbance at 425 and 428 nm for BPB and BCG, respectively. The developed method was validated as per ICH guidelines.

Results: With BPB, the ion-pair formed obeyed Beer`s law in the ranges 5 - 40 and 1 - 50 µg/mL for valsartan and ezetimibe, respectively. The assay data for valsartan and ezetimibe were, 99.39 ± 0.53 and 98.17 ± 0.91 %, respectively, for the commercial formulation, and 99.41 ± 0.48 and 98.16± 0.89 %, respectively, for the developed formulation. The method was validated and the correlation coefficient for valsartan and ezetimibe were 0.995 and 0.999, respectively. Recovery was in the range 99.3 - 100.3 %.

Conclusion: The proposed method is reproducible, accurate, robust and suitable for the simultaneous quantitative analysis of the studied drugs in bulk and dosage formulation.

Keywords: Valsartan, Ezetimibe, Bromophenol blue, Bromocresol green, Spectrophotometric method