Table of Contents
Chromatography Research International
Volume 2011 (2011), Article ID 243491, 7 pages
http://dx.doi.org/10.4061/2011/243491
Research Article

Development and Validation of New Chromatographic Method for the Determination of Enantiomeric and Diastereomeric Purity of Solifenacin Succinate: An Antimuscarinic Agent

1Research and Development, Megafine Pharma (P) Ltd., Nashik 422202, India
2Department of Chemistry, Organic Chemistry Research Center, K.R.T. Arts, B.H. Commerce and A.M. Science College, Gangapur Road, Nashik 422002, India
3Daicel Chiral Technologies (India) Pvt. Ltd., Hyderabad 500078 AP, India

Received 27 July 2010; Accepted 27 September 2010

Academic Editor: Cristina Minguillón

Copyright © 2011 Shashikant B. Landge 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 new, simple, and rapid stereoselective normal phase-liquid chromatographic (NP-LC) method was developed to separate and quantify the solifenacin succinate and its three stereoisomers. The stereoisomeric separation was achieved on Chiralpak IC ( 2 5 0 × 4 . 6  mm ID) column. The mobile phase was consisting of n-hexane, ethanol, isopropyl alcohol, and diethylamine in the ratio (60 : 15 : 25 : 0.1, v/v/v/v), and the flow rate was maintained at 1.0 mL min−1. UV detection was carried out at 220 nm. In addition, chiroptical detection was carried out using laser polarimeter to understand the elution orders. Resolution between all the stereoisomers was not less than 3. Effect of column temperature on resolution between the stereoisomers was studied. The method was validated as per ICH guideline and found to be robust. The proposed NP-LC method was successfully applied to the analysis of commercial formulation. The method could be of use not only for routine evaluation of the quality of solifenacin succinate in bulk drug manufacturing unit but also for detection of impurities in pharmaceutical formulations.