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Development and Validation of Highly Sensitive Method for Determination of Misoprostol Free Acid in Human Plasma by Liquid Chromatography-Electrospray Ionization Tandem Mass Spectrometry: Application to a Clinical Pharmacokinetic Study

Development and Validation of Highly Sensitive Method for Determination of Misoprostol Free Acid in Human Plasma by Liquid Chromatography-Electrospray Ionization Tandem Mass Spectrometry: Application to a Clinical Pharmacokinetic Study

D Vijaya Bharathi, B Jagadeesh, Kishore Kumar Hotha, Uday Patil, Indu Bhushan

J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Sep 15;879(26):2827-33.

PMID: 21872541

Abstract:

A highly sensitive, selective and evaporation free SPE extraction, ESI-LC-MS/MS method has been developed for estimation of misoprostol free acid in human plasma using misoprostol acid-d(5) as an internal standard (IS). The analyte was separated using isocratic mobile phase on reverse phase column and analyzed by MS/MS in the multiple reaction monitoring mode using the respective [M-H] anions, m/z 367-249 for misoprostol acid and m/z 372-249 for the IS. The total run time was 5.0 min and the elution of misoprostol acid and misoprostol acid-d(5) (IS) occurred at 3.6 min. The developed method was validated in human plasma with a lower limit of quantification of 2.5 pg/mL. A linear response function was established for the range of concentrations 2.5-1200 pg/mL (r>0.998) for misoprostol acid in human plasma. The intra and inter-day precision values for misoprostol acid met the acceptance as per FDA guidelines. Misoprostol acid was stable in the battery of stability studies viz., bench-top, auto-sampler and freeze/thaw cycles. The developed assay method was applied to an oral pharmacokinetic study in humans.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP112137890	Misoprostol free acid		112137-89-0	Price

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