Determination of solifenacin in human plasma by liquid chromatography-tandem mass spectrometry.
A liquid chromatography-electrospray tandem mass spectrometry method was developed and validated to quantitate solifenacin in human plasma. The assay was based on protein precipitation with methanol and liquid chromatography performed on a pentafluorophenylpropylsilica column (50×4mm, 3μm particles), the mobile phase consisted of methanol - 100mM ammonium acetate containing 1% of formic acid (90:10, v/v). Quantification was through positive-ion mode and selected reaction monitoring at m/z 363→193 and 368→198 for solifenacin and the internal standard solifenacin-D(5), respectively. The lower limit of quantitation was 0.47ng/ml using 0.25ml of plasma and linearity was demonstrated up to 42ng/ml. Intra-assay and inter-assay precision expressed by relative standard deviation was less than 11% and inaccuracy did not exceed 11% at all levels. The assay was applied to the analysis of samples from a pharmacokinetic study.
Pharmakl s.r.o., Seydlerova 2451, CZ-15800 Prague 13, Czech Republic. macek@pharmakl.cz
Jan
J
Macek
Pavel
P
Ptáček
Josef
J
Klíma
D000328:Adult; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D011812:Quinuclidines / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D000069464:Solifenacin Succinate; D053719:Tandem Mass Spectrometry / Q000379:methods*; D044005:Tetrahydroisoquinolines / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics
D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate