Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 7 Issue 2

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.

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

References

  1. Thomas K and Saadabadi A. “Olanzapine”. Updated 2022 May 2. In: StatPearls Internet. Treasure Island (FL): StatPearls Publishing; (2022).
  2. Navari RM., et al. “Olanzapine for the Treatment of Advanced Cancer-Related Chronic Nausea and/or Vomiting: A Randomized Pilot Trial”. JAMA Oncology6 (2020): 895-899.
  3. Medication Guide: Zyprexa (Olanzapine) Tablet and Zyprexa Zydis (Olanzapine). (2010).
  4. Olanzapine Teva film-coated tablets SUMMARY OF PRODUCT CHARACTERISTICS.
  5. Public Assessment Report of the Medicines Evaluation Board in the Netherlands (CBG-EMB). Olanzapine Jubilant 2.5, 5, 7.5, 10, 15 and 20 mg film-coated tablets (30 August 2010).
  6. Bergemann N., et al. “Olanzapine plasma concentration, average daily dose, and interaction with co-medication in schizophrenic patients”. Pharmacopsychiatry 37 (2004): 63-68.
  7. Titier K., et al. “High-performance liquid chromatographic method with diode array detection to identify and quantify atypical antipsychotics and haloperidol in plasma after overdose”. Journal of Chromatography. B, Biomedical Applications 788 (2003): 179-185.
  8. Dusci LJ., et al. “Determination of olanzapine in plasma by high-performance liquid chromatography using ultraviolet absorbance detection”. Journal of Chromatography. B, Biomedical Applications 773 (2002): 191-197.
  9. Boulton DW., et al. “A high-performance liquid chromatography assay with ultraviolet detection for olanzapine in human plasma and urine”. Journal of Chromatography. B, Biomedical Applications 759 (2001): 319-323.
  10. Raggi MA., et al. “Determination of the novel antipsychotic drug olanzapine in human plasma using HPLC with amperometric detection”. Chromatographia 51 (2000): 562-566.
  11. Raymond NX., et al. “Recent advances in high-throughput quantitative bioanalysis by LC–MS/MS”. Journal of Pharmaceutical and Biomedical Analysis 44 (2007): 342-355.
  12. Bogusz MJ., et al. “Monitoring of olanzapine in serum by liquid chromatography atmospheric pressure chemical ionization mass spectrometry”. Journal of Chromatography B: Biomedical Sciences 732 (1999): 257-269.
  13. Berna M., et al. “Determination of olanzapine in human plasma and serum by liquid chromatography/tandem mass spectrometry”. Journal of Mass Spectrometry 33 (1998): 1003-1008.
  14. Dinesh S Patel., et al. “LC–MS/MS assay for olanzapine in human plasma and its application to a bioequivalence study”. Acta Pharmaceutica Sinica B5 (2012): 481-494.
  15. Bedor Noely., et al. “The development and validation of a method for quantifying olanzapine in human plasma by liquid chromatography tandem mass spectrometry and its application in a pharmacokinetic study”. Clinical and Experimental Pharmacology and Physiology 42 (2014).
  16. Berna M., et al. “Determination of olanzapine in human blood by liquid chromatography-tandem mass spectrometry”. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences 767 (2002): 163-168.
  17. Bioavailability Studies Submitted in NDAs or INDs — General Considerations, April 2022 (2022).
  18. Guidance for Industry Bioanalytical Method Validation (May 2018).
  19. Ping Du., et al. “Optimized UPLC–MS/MS method for the quantitation of olanzapine in human plasma: application to a bioequivalence study”. Bioanalysis13 (2019): 1291-1302.
  20. Cao Jing., et al. “Liquid Chromatography-Mass Spectrometry Method for the Determination of Olanzapine in Human Plasma and Application to a Bioequivalence Study”. Current Pharmaceutical Analysis3 (2012): 247-254.
  21. Nagwa A Sabri., et al. “Cefixime and Management Protocols for COVID-19 Second Wave. Does its Accurate Detection in Human Plasma Make Sense?". Acta Scientific Pharmaceutical Sciences1 (2021): 46-53.
  22. Kang D., et al. “Association between olanzapine concentration and metabolic dysfunction in drug-naive and chronic patients: similarities and differences”. Schizophr 8 (2022): 9.
  23. Bhana N., et al. “Olanzapine: an updated review of its use in the management of schizophrenia”. Drugs1 (2001): 111-161.
  24. Ostuzzi G., et al. “Safety of psychotropic medications in people with COVID-19: evidence review and practical recommendations”. BMC Medicine 18 (2020): 215.
  25. Xie Q., et al. “COVID-19 patients managed in psychiatric inpatient settings due to first-episode mental disorders in Wuhan, China: clinical characteristics, treatments, outcomes, and our experiences”. Translational Psychiatry 10 (2020): 337.
  26. Nagwa A Sabri., et al. “Management Protocols Deviation of COVID-19 in Diabetic Patients. Is it Applicable?". Acta Scientific Pharmaceutical Sciences2 (2021): 57-66.
  27. Satoshi Ninagawa., et al. “Antipsychotic olanzapine-induced misfolding of proinsulin in the endoplasmic reticulum accounts for atypical development of diabetes”. eLife (2020).
  28. Toledo FGS., et al. “Insulin and glucose metabolism with olanzapine and a combination of olanzapine and samidorphan: exploratory phase 1 results in healthy volunteers”. Neuropsychopharmacology 3 (2022): 696-703.
  29. Alastanos JN., et al. “A case report and literature review of olanzapine-associated hyperglycemia with previous history of gestational diabetes”. Mental Health Clinics1 (2022): 37-44.

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.




Metrics

Acceptance rate32%
Acceptance to publication20-30 days

Indexed In




News and Events


Contact US