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

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.