Quantification of propiverine by liquid chromatography/electrospray tandem mass spectrometry: application to a bioequivalence study of two formulations in healthy subjects.
Here we report on the development and validation of a sensitive and rapid reversed-phase liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the quantitative determination of propiverine in human plasma. After adding an internal standard (oxybutynin chloride) to human plasma, samples were extracted using n-hexane/ethylacetate (8:2, v/v). Compounds extracted were analyzed by reversed-phase high-performance liquid chromatography (HPLC) with multiple reaction monitoring (MRM) mode for analyte detection. This method for determination of propiverine proved accurate and reproducible, with a limit of quantitation of 0.5 ng/ml in human plasma. The standard calibration curve for propiverine was linear (r2=0.9988) over the concentration range 0.5-1000.0 ng/ml in human plasma. The intra- and inter-day precision over this concentration range was lower than 8.66% (relative standard deviation, %R.S.D.), and accuracy was between 99.46 and 109.41%, respectively. This method was successfully applied to a bioequivalence study of two propiverine hydrochloride tablet formulations (20 mg) in 24 healthy subjects after a single administration.
Cho
Sung-Hee
SH
Department of Biochemistry, College of Pharmacy, Kyung-Hee University, Dongdaemun-Ku, Hoegi-Dong, Seoul 130-701, South Korea.
Lee
Hun-Woo
HW
Im
Ho-Taek
HT
Park
Wan-Su
WS
Baek
Minsun
M
Lee
Kyung-Tae
KT
D019540:Area Under Curve; D001561:Benzilates / Q000032:analysis* / Q000097:blood / Q000737:chemistry; D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002851:Chromatography, High Pressure Liquid; D002853:Chromatography, Liquid / Q000379:methods*; D004345:Drug Industry / Q000379:methods; D006493:Heparin / Q000737:chemistry; D006801:Humans; D008333:Mandelic Acids / Q000032:analysis / Q000737:chemistry; D013058:Mass Spectrometry; D008956:Models, Chemical; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D013607:Tablets; D013810:Therapeutic Equivalency; D013997:Time Factors
D001561:Benzilates; D008333:Mandelic Acids; D013607:Tablets; C015586:propiverine; D006493:Heparin; C005419:oxybutynin