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Simultaneous estimation of 16 α ‐hydroxycleroda‐3,13(14) Z ‐dien‐15,16‐olide from Polyalthia longifolia and its metabolite in hamster plasma: application to pharmacokinetic study
Author(s) -
Bhatta R. S.,
Kumar Devendra,
Chhonker Y. S.,
Kumar Deepak,
Singh Suriya P.,
Sashidhara Koneni V.,
Jain G. K.
Publication year - 2012
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.1672
Subject(s) - chemistry , metabolite , chromatography , pharmacokinetics , plasma , pharmacology , biochemistry , medicine , physics , quantum mechanics
A selective and sensitive LC–MS‐MS method was developed and validated for simultaneous estimation and pharmacokinetic studies of 16 α ‐hydroxycleroda‐3,13(14) Z ‐dien‐15,16‐olide (K‐09) obtained from Polyalthia longifolia and its metabolite (K‐9T), a novel antidyslipidemic agent. Sample clean‐up involved liquid–liquid extraction of both the analytes and internal standard (rosuvastatin) from 200 μL of hamster plasma. The analytes were chromatographically separated on a Symmetry‐Shield C 18 (5 µm, 4.6 × 150 mm) column, using acetonitrile–0.1% aqueous formic acid (92:08, v/v) as the mobile phase. Detection was performed using negative ion electrospray ionization in multiple reaction monitoring mode. The MS/MS response was linear over the concentration range 1.56–200 ng/mL, with a correlation coefficient ( r 2 ) of 0.998 or better. The within‐ and between‐batch precisions (relative standard deviation, %RSD) and the accuracy (percentage bias) were within acceptable limits as per FDA guidelines. The validated method was successfully applied to reveal the pharmacokinetic parameters of K‐09 and metabolite after oral administration. This method will therefore be highly useful for future studies of K‐09 and metabolite K‐9T pharmacokinetics in preclinical and clinical studies. Copyright © 2011 John Wiley & Sons, Ltd.