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.
Highlights
Solifenacin succinate is a competitive muscarinic acetylcholine receptor antagonist used in the treatment of overactive bladder with or without urge incontinence
The main goal of the present study is to develop and validate the novel simple, higher sensitive, selective, rapid, rugged, and reproducible bioanalytical method for quantitative determination of SF in rat plasma by LC-MS/MS with a small amount of sample volume
Chromatographic conditions, especially the composition and nature of the mobile phase, usage of different columns, and different extraction methods such as solid phase, precipitation, and liquid-liquid extraction methods were optimized through several trials to achieve the best resolution and increase the signal of SF and SFD5
Summary
Solifenacin succinate is a competitive muscarinic acetylcholine receptor antagonist used in the treatment of overactive bladder with or without urge incontinence. Solifenacin-d5 (SFD5) used as an internal standard. Drug and IS were extracted by Liquid- liquid extraction method. The method was validated with the correlation coefficients of (r2) ≥ 0.9975 over a linear concentration range of 0.1-100.0 ng/mL. One pharmacologically active metabolite (4R-hydroxy Solifenacin) occurs at low concentrations and three pharmacologically inactive metabolites (N-glucuronide and the N-oxide and 4Rhydroxy-N-oxide of Solifenacin) in human plasma after oral dosing.
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