Bioanalytical method for quantification of Solifenacin in rat plasma by LC-MS/MS and its application to pharmacokinetic study

Abstract

Abstract Background Solifenacin succinate is a competitive muscarinic acetylcholine receptor antagonist used in the treatment of overactive bladder with or without urge incontinence. Methods Liquid chromatography–tandem mass spectrometry method was used for quantification of Solifenacin (SF) in rat plasma. Solifenacin-d5 (SFD5) used as an internal standard. Chromatographic separation was performed Gemini-NX C18, 50 × 4.6 mm, 5 µm, 110 Å column. Mobile phase composed of 5 mM Ammonium formate, pH 3.0: methanol (20:80 v/v), with 0.4 mL/min flow-rate. Drug and IS were extracted by Liquid- liquid extraction method. SF and SFD5 were detected with proton adducts at m/z 363.2®193.2 and 368.2®198.2 in multiple reaction monitoring (MRM) positive mode respectively. The method was validated with the correlation coefficients of (r2) ≥ 0.9975 over a linear concentration range of 0.1-100.0 ng/mL. Results This method demonstrated intra and inter-day precision within 1.09 to 4.84 and 1.75 to 7.68 % and accuracy within 101.21 to 106.67 and 97.94 to 104.79 % for SF. Conclusions This method is successfully applied in the Pharmacokinetic study of rat plasma.