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.

Received: October 17, 2022; Published: January 06, 2023

Abstract

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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Citation

Citation: Nagwa A Sabri., et al. “Determination of Olanzapine in Human Plasma by LC/MS/MS and its Clinical Applications". Acta Scientific Pharmaceutical Sciences 7.2 (2023): 10-19.

Copyright

Copyright: © 2022 Nagwa A Sabri., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.