Optimized UPLC-MS/MS method for the quantitation of olanzapine in human plasma: application to a bioequivalence study.

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Optimized UPLC-MS/MS method for the quantitation of olanzapine in human plasma: application to a bioequivalence study.

Bioanalysis. 2019 Aug 05;:

Authors: Du P, Li P, Zhao R, Liu H, Liu L

Abstract
Aim: Olanzapine (OLZ) is the first-line, cost-effectiveness treatment for schizophrenia in China. A quantitative ultrahigh performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for determination of OLZ in human plasma was developed. Results: LC separation was achieved on Waters XBrige C18 column. ESI+ was involved and multiple reaction monitoring transitions were at m/z 313.2→256.1 for OLZ and m/z 316.2→256.1 IS (d3-OLZ). The linear range was 0.1-20 ng/ml with LLOQ of 0.1 ng/ml. Accuracy and precision were within 10%. The validated method was successfully applied to a bioequivalence study of OLZ disintegrating tablets at dose of 5 mg with 100% reproducibility evaluated by incurred sample reanalysis. Conclusion: A robust validated method was developed for quantitation of OLZ in human plasma.

PMID: 31379195 [PubMed - as supplied by publisher]