development and validation of new chromatographic method for the determination of enantiomeric and diastereomeric purity of solifenacin succinate an antimuscarinic agent开发和验证新的色谱方法测定对映体和非对映的纯洁的琥珀酸solifenacin antimuscarinic代理.pdfVIP

SAGE-Hindawi Access to Research Chromatography Research International Volume 2011, Article ID 243491, 7 pages doi: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 Shashikant B. Landge,1, 2 Sanjay A. Jadhav,1 Sunil B. Dahale,1 Navanath C. Niphade,1 Ch. Lakshmi Narayana,3 Vishwas B. Gaikwad,2 and Vijayavitthal T. Mathad1 1 Research and Development, Megafine Pharma (P) Ltd., Nashik 422202, India 2 Department of Chemistry, Organic Chemistry Research Center, K.R.T. Arts, B.H. Commerce and A.M. Science College, Gangapur Road, Nashik 422002, India 3 Daicel Chiral Technologies (India) Pvt. Ltd., Hyderabad 500078 AP, India Correspondence should be addressed to Vijayavitthal T. Mathad, drvtmathad@yahoo.co.in Received 27 July 2010; Accepted 27 September 2010 ´ Academic Editor: Cristina Minguillon 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. 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 (250 × 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,