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Published:
Journal of Analytical Toxicology,
ISSN 0146-4760,
Volume 32, Number 3, April,
pp.253-259
Determination
of Lovastatin Hydroxy Acid in Female B6C3F1 Mouse Serum
Jon W. Lodge1, Brenda L. Fletcher1, Sherri S. Brown1, Angela J.
Parham1, and Reshan A. Fernando1, Bradley J. Collins2
1RTI International, P.O. Box 12194, Research Triangle Park, North
Carolina 27709-2194
2NIEHS/National Toxicology Program, P.O. Box 12233, Research Triangle
Park, North Carolina 27709-2233
A liquid chromatographic–mass spectrometricmethod
for the determination of lovastatin hydroxy acid in female B6C3F1
mouse serum was developed for use in supporting toxicokinetic
studies of animals dosed with the cholesterol lowering agent
lovastatin. The method does not require an extensive sample cleanup
and shows good correlation between serum matrix standards and
solvent standards. The method was validated and used to analyze
serum samples from a preliminary dose level range-finding study.
The method was validated for a concentration range of approximately
1.0 to 100 ng/mL in serum, and linearity was verified to ~2000
ng/mL. The stability of sample extracts was determined under
various storage conditions and the stability of serum samples
stored frozen was determined over a period of seven weeks. During
the course of analyzing the animal samples, the serum was monitored
for the presence of lovastatin not hydrolyzed to the hydroxy
acid, but no attempt was made to quantify lovastatin. No unhydrolyzed
lovastatin was noted in any of the serum samples from animals
dosed with lovastatin.
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