原创力文档development and validation of stability-indicating hptlc determination of tamsulosin in bulk and pharmaceutical dosage form开发和验证stability-indicating效果测定tamsulosin散装和制药剂型.pdfVIP
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development and validation of stability-indicating hptlc determination of tamsulosin in bulk and pharmaceutical dosage form开发和验证stability-indicating效果测定tamsulosin散装和制药剂型
SAGE-Hindawi Access to Research
Chromatography Research International
Volume 2011, Article ID 893260, 6 pages
doi:10.4061/2011/893260
Research Article
Development and Validation of Stability-Indicating
HPTLC Determination of Tamsulosin in Bulk and
Pharmaceutical Dosage Form
S. B. Bari, A. R. Bakhshi, P. S. Jain, and S. J. Surana
R. C. Patel Institute of Pharmaceutical Education and Research (RCPIPER), Shirpur, District Dhule, Maharashtra 425 405, India
Correspondence should be addressed to P. S. Jain, pritash79@
Received 14 October 2010; Accepted 20 December 2010
´
Academic Editor: Cristina Minguillon
Copyright © 2011 S. B. Bari 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 simple, economic, selective, precise, and stability-indicating high-performance thin-layer chromatographic method for analysis
of tamsulosin hydrochloride, both as a bulk drug and in formulations, was developed and validated according to ICH guidelines.
The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase while the solvent system
consisted of toluene : methanol : triethylamine (3.5 : 1.2 : 0.2 v/v). The system was found to give compact spot for drug (Rf value
of 0.52 ± 0.02). Densitometric analysis of tamsulosin was carried out in the absorbance mode at 280 nm. The linear regression
analysis data for the calibration plots showed good linear relationship, r2 = 0.9982 ± 0.0012, with respect to peak area in the
concentration range 400–2400 ng per spot. The mean value ± SD of slope and intercept were 2.6553 ± 0.0173 and 777.7 ± 74.8 wit
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