Two green chromatographic methods for the quantification of tamsulosin and solifenacin along with four of their impurities.

Abstract

Modern analytical procedures often include impurity profiling to verify the potency, safety, and effectiveness of new formulations. We had to develop techniques based on green analysis since the detrimental influence of solvents and chemicals on the environment has now become a serious concern. Two selective, sensitive, and green liquid chromatography methods were established and fully validated for quantitation of tamsulosin hydrochloride and solifenacin succinate along with four of their official and/or related impurities namely; tamsulosin sulfonic acid, tamsulosin impurity H, solifenacin impurity A and solifenacin impurity C. The first used high-performance thin-layer chromatography with silica gel 60 F254 plates as the stationary phase and an elution system of ethyl acetate:butanol:glacial acetic acid (10.0:0.4:0.1, by volume) and a scanning wavelength of 225.0nm. The second method depended on HPLC with diode array detection. Chromatographic separation was accomplished on a Zorbax SB C18 (250 × 4.6 mm2 , 5 μm) column utilizing a mixture of 10.0mM sodium dihydrogen phosphate (pH 3.0, adjusted by o-phosphoric acid) and methanol, at a flow rate of 0.8mL/min in a gradient elution mode and then the separated peaks were scanned at a wavelength of 225.0nm. To assess the greenness profile, three distinct methodologies were applied.