Quantification of Tamsulosin Hydrochloride and Solifenacin Succinate by Discriminative Derivative Synchronous Emission Spectroscopy

[摘要] Objectives: The present study was undertaken with the objective to develop and validate a simple spectrofluorimetric method for the simultaneous quantification of tamsulosin hydrochloride and solifenacin succinate. Materials and Methods: First-derivative synchronous spectrofluorimetry was attempted for the simultaneous quantification of the analytes. Tamsulosin hydrochloride was quantified at a wavelength of 322 nm (zero-crossing wavelength point of solifenacin succinate) and solifenacin succinate was measured at 570 nm (zero-crossing wavelength point of tamsulosin hydrochloride). Results: Calibration plots were constructed over the concentration range of 2-10 µg/mL for tamsulosin hydrochloride and 30-150 µg/mL for solifenacin succinate. The method gave satisfactory results when it is validated for linearity, specificity, accuracy, precision, LOD and LOQ as per the ICH guidelines. The assay values in the commercial formulation were found to be in the percentage range of 95.0 for tamsulosin hydrochloride and 103.5 for solifenacin succinate by the proposed method. These results were well in agreement with their label claim. Conclusion: The proposed synchronous analytical method can be employed for routine quality control analysis of tamsulosin hydrochloride/ solifenacin succinate in tablet dose forms.

[关键词] Tamsulosin hydrochloride;solifenacin succinate;synchronous spectrofluorimetry;method validation