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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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. Misoprostolacid-d5 was used as in internal standard (IS). The analyte and IS were extracted by simple one step solid phaseextraction (SPE). Linearity in plasma was obtained over the concentration range 10~3000 pg/mL and lowerlimit of quantification (LLOQ) was identifiable and reproducible at 10 pg/mL. The intra- and inter-day precisionvalues 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 misoprostolacid in human plasma after an oral administration of 0.4 mg misoprostol.
Abstract
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. Misoprostolacid-d5 was used as in internal standard (IS). The analyte and IS were extracted by simple one step solid phaseextraction (SPE). Linearity in plasma was obtained over the concentration range 10~3000 pg/mL and lowerlimit of quantification (LLOQ) was identifiable and reproducible at 10 pg/mL. The intra- and inter-day precisionvalues 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 misoprostolacid in human plasma after an oral administration of 0.4 mg misoprostol.
참고문헌 (15)
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