Xây dựng phương pháp định lượng Solifenacin trong huyết tương người bằng phương pháp LC-MS/MS

Abstract

A high and specific method using ultra performance liquid chromatography tandem mass spectrometry for determination of solifenacin in human plasma was developed. Solifenacin-d5 were utilized as internal standard. Analytes were extracted from plasma by liquid-liquid extraction method using tert-butyl methyl ether. Liquid chromatography was performed on Hypersil Gold C18; 50 x 2.1 mm; 1.9 µm column with of 5 mM ammonium acetate, with 0.1% formic acid and acetonitrile as mobile phase at flow rate of 0.2 mL per minute. The method has a rapid analysis time and LLOQ value and standard curves were found to be linear in the wide range 0.1 to 25.0 ng/mL. The method’s precision and accurary are within acceptable limit. The validated method has been used successfully to determine solifenacin concentration in healthy adult volunteers and demonstrate its applicability to bioavailability/bioequivalence studies of solifenacin preparations.