Determination of Olanzapine in Human Plasma by LC/MS/MS and its Clinical Applications
Mohamed Raslan1, Eslam MS1, Sara AR1 and Nagwa A Sabri2*
1Drug Research Centre, Cairo, Egypt
2Department of Clinical Pharmacy, Faculty of Pharmacy- Ain Shams University, Cairo, Egypt
*Corresponding Author: Nagwa A Sabri, Department of Clinical Pharmacy, Faculty of Pharmacy- Ain Shams University, Cairo, Egypt.
October 17, 2022; Published: January 06, 2023
Background: Olanzapine is a medication used in the treatment of schizophrenia and bipolar disorders which are typically appearing between the late teenage years and the mid-30s.
Aim: Development of a sensitive, robust, and cost effective bio-analytical method for rapid quantification of olanzapine in biological fluids and its application in pharmacokinetics, bioavailability studies, and clinical trials.
Methods: Olanzapine was extracted from plasma samples by liquid-liquid extraction method, and chromatographed with an eluting solvent consisting of Methanol: 0.5% Formic acid 60: 40 V/V at a flow rate of 0.5 ml/min, ESI positive mode, and m/z 313.2 à 256.1, 327 à 270 for olanzapine and clozapine as internal standard respectively. The method was applied for plasma sample analysis of comparative bioavailability study of Olanzapine 7.5mg generic versus reference tablets. The criteria used to assess the bioequivalence of the two products were the non significance of Cmax, AUC 0-72, and Tmax statistical analysis.
Results: The method showed to be more sensitive, specific, linear, accurate, precise, and cost-effective. The average recovery of olanzapine from human plasma was 91.118% with a limit of quantitation of 0.025ng/ml and the linearity (r2) obtained was 0.9998. Moreover, statistical analysis (ANOVA) of the measured pharmacokinetic parameters showed that there was no significance between the two products.
Conclusion: The developed bioanalytical LC/MS/MS method is valid and reliable for olanzapine quantification in human plasma. Furthermore, the method is suitable for application in pharmacokinetic studies and therapeutic monitoring of olanzapine in the management of schizophrenia, bipolar disorders, and other diseases. On the other hand, the comparative bioavailability study results showed that both generic and reference tables are bioequivalent.
Keywords: Olanzapine; Schizophrenia; LC/MS/MS; Validation; Liquid-liquid Extraction
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