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KMID : 0385520150280010017
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Analytical Science & Technology
2015 Volume.28 No. 1 p.17 ~ p.25
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Development and validation of a selective and sensitive LC-MS/MS method for determination of misoprostol acid in human plasma: Application to bioequivalence study
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Park Yong-Sun
Kim Ye-Na
Kim Jin-Young
Sim Soo-Ji
Lee Heon-Soo
Kim Keun-Nam
Kim Jung-Hwan
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Abstract
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A rapid, sensitive and specific method was developed and validated using electrospray ionization (ESI) tandem mass spectrometry (LC-MS/MS) for determination of misoprostol acid in human plasma. Misoprostol acid-d5 was used as in internal standard (IS). The analyte and IS were extracted by simple one step solid phase extraction (SPE). Linearity in plasma was obtained over the concentration range 10~3000 pg/mL and lower limit of quantification (LLOQ) was identifiable and reproducible at 10 pg/mL. The intra- and inter-day precision values were below 9% and the accuracy was ranged from 93.81% to 102.02% at all four quality control samples. The method was has been successfully applied for routine assay to support pharmacokinetic study of misoprostol acid in human plasma after an oral administration of 0.4 mg misoprostol.
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KEYWORD
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misoprostol acid, alsoben, human plasma, LC-MS/MS, pharmacokinetics,
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