Stability Indicating HPLC Method for Quantification of Solifenacin Succinate & Tamsulosin Hydrochloride along with Its Impurities in Tablet Dosage Form
Open Access
- 1 January 2016
- journal article
- research article
- Published by Scientific Research Publishing, Inc. in American Journal of Analytical Chemistry
- Vol. 07 (11), 840-862
- https://doi.org/10.4236/ajac.2016.711073
Abstract
A novel stability-indicating RP-HPLC method was developed and validated for simultaneous determination of Solifenacin Succinate & Tamsulosin Hydrochloride and its impurities in tablet dosage form. The method was developed using L1 column with gradient using the mobile phase consist of solvent-A (pH = 6.6, phosphate buffer + 0.5% Triethylamine) and solvent-B (90% Acetonitrile). The eluted compounds were monitored at 225 nm. Solifenacin Succinate & Tamsulosin Hydrochloride was subjected to oxidative, acid, base, hydrolytic, thermal and photolytic stress conditions. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The limit of quantification results was ranged from 0.135 - 0.221 μg/mL for Solifenacin Succinate impurities and 0.043 - 0.090 μg/mL for Tamsulosin Hydrochloride impurities. This method is suitable for the estimation of impurities and assay of Solifenacin Succinate & Tamsulosin Hydrochloride in tablets dosage form.Keywords
This publication has 7 references indexed in Scilit:
- Cost-effectiveness of a fixed-dose combination of solifenacin and oral controlled adsorption system formulation of tamsulosin in men with lower urinary tract symptoms associated with benign prostatic hyperplasiaBMC Urology, 2015
- Bioanalytical method for quantification of Solifenacin in rat plasma by LC-MS/MS and its application to pharmacokinetic studyJournal of Analytical Science and Technology, 2014
- Effects of Tamsulosin, Solifenacin, and Combination Therapy for the Treatment of Ureteral Stent Related DiscomfortsKorean Journal of Urology, 2011
- A Validated Rapid Stability-Indicating Method for the Determination of Related Substances in Solifenacin Succinate by Ultra-Fast Liquid ChromatographyJournal of Chromatographic Science, 2010
- Determination of solifenacin succinate, a novel muscarinic receptor antagonist, and its major metabolite in rat plasma by semi-micro high performance liquid chromatographyJournal of Chromatography B, 2007
- Rapid, simple and highly sensitive LC-ESI-MS/MS method for the quantification of tamsulosin in human plasmaBiomedical Chromatography, 2005
- TamsulosinDrugs & Aging, 2002