Stability Indicating HPLC Method for Quantification of Solifenacin Succinate &Tamsulosin Hydrochloride along with Its Impurities in Tablet Dosage Form  

作　　者：Hari Kishan Reddy Ganthi Raveendra Reddy P Young Jun Park Hanimi Reddy Bapatu So Jin Park Woo Hyong Cho Hari Kishan Reddy Ganthi;Raveendra Reddy P;Young Jun Park;Hanimi Reddy Bapatu;So Jin Park;Woo Hyong Cho(Department of Chemistry, Sri Krishnadevaraya University, Anantapur, India;Celltrion Chemical Research Institute, Youngin, South Korea)

机构地区：[1]Department of Chemistry, Sri Krishnadevaraya University, Anantapur, India [2]Celltrion Chemical Research Institute, Youngin, South Korea

出　　处：《American Journal of Analytical Chemistry》2016年第11期840-862,共23页美国分析化学（英文）

摘　　要：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.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.

关 键 词：SOLIFENACIN TAMSULOSIN RP-HPLC IMPURITIES Method Validation 

分 类 号：R98[医药卫生—药品]