Table of Contents
Chromatography Research International
Volume 2014 (2014), Article ID 874587, 9 pages
http://dx.doi.org/10.1155/2014/874587
Research Article

Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Determination of Related Substances of S(−)Amlodipine and S(−)Metoprolol Succinate in Fixed Dose Combination Tablet Dosage Form

Department of Analytical Research and Development, Emcure Pharmaceuticals Limited, CO 10(12) Functional Electronic Estate, M.I.D.C., Bhosari, Pune 411026, India

Received 14 August 2014; Accepted 30 September 2014; Published 20 October 2014

Academic Editor: Toyohide Takeuchi

Copyright © 2014 Suresh Shitole et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

A novel, rapid, accurate, sensitive, precise, and stability-indicating reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method was developed and validated for determination of related substances of S(−)Amlodipine and S(−)Metoprolol Succinate in fixed dose combination tablet dosage form. The chromatographic separation was achieved with the use of Acquity UPLC HSS T3, 1.8 μm, 2.1 × 100 mm analytical column at 45°C employing a gradient elution. Mobile phase consisting of mobile phase-A (solution containing 5.0 gm of sodium dihydrogen phosphate monohydrate per liter of water and Acetonitrile in the ratio of 95 : 5) and mobile phase-B (Acetonitrile) was used at a flow rate of 0.5 mL min−1 with injection volume of 10 μL and the detection was done at 232 nm using UV detector. The retention times of S(−)Metoprolol Succinate and S(−)Amlodipine were found to be 2.8 minutes and 8.1 minutes, respectively. During method validation all the parameters were evaluated as per ICH guidelines, which remained well within acceptable limits. This method can be used for the estimation of related substances of S(−)Amlodipine and S(−)Metoprolol Succinate in fixed dose combination tablet dosage form.