Table of Contents
Chromatography Research International
Volume 2012, Article ID 356216, 7 pages
http://dx.doi.org/10.1155/2012/356216
Research Article

Stability-Indicating RP-TLC/Densitometry Determination of Raloxifene Hydrochloride in Bulk Material and in Tablets

Department of Pharmaceutical Chemistry, R.C. Patel Institute of Pharmaceutical Education and Research, Karwand Naka, Shirpur, Dhule District 425 405, India

Received 15 February 2012; Accepted 16 March 2012

Academic Editor: Sibel A. Ozkan

Copyright © 2012 A. A. Shirkhedkar 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 stability-indicating RP-TLC/Densitometry method for analysis of Raloxifene hydrochloride both in bulk material and in tablets was developed and validated. Densitometric analysis of Raloxifene hydrochloride was carried out at 311 nm on TLC aluminium plates precoated with silica gel 60RP-18 F254S as the stationary phase and methanol : water : ammonia (95 : 05 : 0.1 v/v) as mobile phase. Raloxifene hydrochloride was well resolved at Rf 0.55 ± 0.02. The linear regression analysis data for the calibration plots showed good linear relationship with r2=0.9969±0.0015 with respect to peak area in the concentration range 100–600 ng per band. The mean value ± SD of slope and intercept was found to be 15.05±0.44 and 201.9±29.58 with respect to peak area. The limits of detection and quantification were 9.27 ng and 27.10 ng, respectively. Raloxifene hydrochloride was subjected to acid and alkali hydrolysis, oxidation, dry heat, and photodegradation. The drug underwent degradation under basic and oxidation conditions. This indicates that the drug is susceptible to alkali hydrolysis and oxidation. The proposed developed RP-TLC/Densitometry method can be applied for identification and quantitative determination of Raloxifene hydrochloride in bulk material and tablets.