Liquid chromatography–tandem mass spectrometry quantification of levosulpiride in human plasma and its application to bioequivalence study

An improved method for determining levels of levosulpiride in human plasma using ultra-performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) was developed and validated. The protein precipitation method was used for plasma sample preparation. Levosulpiride and an internal standard...

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Veröffentlicht in:Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Analytical technologies in the biomedical and life sciences, 2010-08, Vol.878 (24), p.2280-2285
Hauptverfasser: Phapale, Prasad B., Lee, Hae Won, Lim, Mi-sun, Seong, Sook Jin, Kim, Eun-Hee, Park, Jeonghyeon, Lee, Miran, Hwang, Sung-Kyu, Yoon, Young-Ran
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container_issue 24
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container_title Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
container_volume 878
creator Phapale, Prasad B.
Lee, Hae Won
Lim, Mi-sun
Seong, Sook Jin
Kim, Eun-Hee
Park, Jeonghyeon
Lee, Miran
Hwang, Sung-Kyu
Yoon, Young-Ran
description An improved method for determining levels of levosulpiride in human plasma using ultra-performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) was developed and validated. The protein precipitation method was used for plasma sample preparation. Levosulpiride and an internal standard (IS) were isocratically separated on a UPLC BEH C 18 column with a mobile phase of ammonium formate buffer (1 mM, adjusted to pH 3 with formic acid) and acetonitrile (60:40, v/v). MS/MS detection was performed by monitoring the parent → daughter pair of levosulpiride and the IS at m/z 342 → 112 and 329 → 256, respectively. The method was linear from 2.5 to 200 ng/mL and exhibited acceptable precision and percent recovery. The method was successfully demonstrated in pharmacokinetic and bioequivalence studies of two levosulpiride oral formulations administered to healthy volunteers. When compared to the previous LC–MS methods, the proposed method is faster, well-validated, and uses lesser plasma volume and a similar sensitivity. The use of UPLC allowed rapid and sensitive quantification of levosulpiride, making this method suitable for high-throughput clinical applications.
doi_str_mv 10.1016/j.jchromb.2010.06.036
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B, Analytical technologies in the biomedical and life sciences</title><addtitle>J Chromatogr B Analyt Technol Biomed Life Sci</addtitle><description>An improved method for determining levels of levosulpiride in human plasma using ultra-performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) was developed and validated. The protein precipitation method was used for plasma sample preparation. Levosulpiride and an internal standard (IS) were isocratically separated on a UPLC BEH C 18 column with a mobile phase of ammonium formate buffer (1 mM, adjusted to pH 3 with formic acid) and acetonitrile (60:40, v/v). MS/MS detection was performed by monitoring the parent → daughter pair of levosulpiride and the IS at m/z 342 → 112 and 329 → 256, respectively. The method was linear from 2.5 to 200 ng/mL and exhibited acceptable precision and percent recovery. 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subjects Acetonitrile
Adult
Analysis
Analytical, structural and metabolic biochemistry
Bioanalytical method validation
Biological and medical sciences
Chromatography
Chromatography, High Pressure Liquid - methods
Formates
Formic acid
Fundamental and applied biological sciences. Psychology
General pharmacology
Human
Human plasma
Humans
Levosulpiride
Liquids
Male
Mass spectrometry
Medical sciences
Parents
Pharmacokinetic study
Pharmacology. Drug treatments
Reproducibility of Results
Sensitivity and Specificity
Sulpiride - analogs & derivatives
Sulpiride - blood
Sulpiride - pharmacokinetics
Tandem Mass Spectrometry - methods
Therapeutic Equivalency
Tiapamil Hydrochloride - analysis
UPLC–MS/MS
title Liquid chromatography–tandem mass spectrometry quantification of levosulpiride in human plasma and its application to bioequivalence study
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