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

Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences
Prasad B PhapaleYoung-Ran Yoon

Abstract

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 (1mM, 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 200ng/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.

References

Oct 15, 2008·Rapid Communications in Mass Spectrometry : RCM·Philip R TillerThomas A Baillie

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Citations

Feb 23, 2011·Bioanalysis·Joanne MatherRobert S Plumb
Dec 17, 2014·Clinica Chimica Acta; International Journal of Clinical Chemistry·Lisbeth PatteetHugo Neels

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