Rapid quantification of levosulpiride in human plasma using RP-HPLC-MS/MS for pharmacokinetic and bioequivalence study.
A rapid and validated method for analysis of levosulpiride in human plasma using liquid chromatography coupled to tandem mass spectrometry was developed. Levosulpiride and tiapride (IS, internal standard) were extracted from alkalized plasma samples with ethylacetate and separation by RP-HPLC. Detection was performed by positive ion electrospray ionization in multiple-reaction monitoring mode, monitoring the transitions m/z 342.1 --> m/z 112.2 and m/z 329.1 --> m/z 213.2, for quantification of levosulpiride and IS, respectively. The standard calibration curves showed good linearity within the range of 2-200 ng/mL (r(2) > or = 0.9990). The lower limit of quantitation was 2 ng/mL. The retention times of levosulpiride (0.63 min) and IS (0.66 min) presented a significant time saving benefit of the proposed method. No significant metabolic compounds were found to interfere with the analysis. This method offered good precision and accuracy and was successfully applied for the pharmacokinetic and bioequivalence study of a 25 mg of levosulpiride tablet in 24 healthy Korean volunteers.
Park
Jin-Hee
JH
Department of Pharmacology and Institute of Biomedical Sciences, College of Medicine, Hanyang University, Seoul, South Korea.
Park
Yoo-Sin
YS
Rhim
Si-Youn
SY
Kim
Hyun-Jin
HJ
Jhee
Ok-Hwa
OH
Lee
Yun-Sik
YS
Lee
Min-Ho
MH
Shaw
Leslie M
LM
Kang
Ju-Seop
JS
D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D018492:Dopamine Antagonists / Q000097:blood* / Q000493:pharmacokinetics; D006801:Humans; D057230:Limit of Detection; D012015:Reference Standards; D013469:Sulpiride / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency
D018492:Dopamine Antagonists; D013469:Sulpiride; C078143:levosulpiride