Temozolomide (TMZ) is one of the most often used drugs in the treatment of malignant primary brain tumors.
The aim of the study was to develop the bioanalytical method for the determination of TMZ in human plasma. A high-performance liquid chromatography method with UV detection (HPLC-UV) is based on the method described by Kim et al. [1]. The method was validated according to European Medicines Agency (EMA) [2] and Food and Drug Administration (FDA) [3] guidelines, in compliance with the principles of Good Laboratory Practice (GLP). Plasma concentration of TMZ was determined on C18 column after liquid-liquid extraction. Isocratic elution was applied with mixture of aqueous acetic acid and methanol. Theophylline was used as an internal standard. To prevent chemical degradation of TMZ to an active metabolite at physiological pH, plasma samples were acidified to pH < 3.
All of the validation parameters met acceptance criteria. Calibration curve, prepared using freshly spiked plasma samples, was linear within the range of 0.1-20.0 µg/mL. The method was found to be sufficiently accurate and precise over the studied range of concentrations. TMZ was stable in acidified plasma samples for at least 50 days. The method recovery of TMZ from human plasma was consistent and ranged 37.1-41.1%.
The study was supported by the European Union (European Regional Development Fund) under the Innovative Economy Operational Programme 2007–2013 (Project No. UDA-POIG.01.03.01-14-069/08).
    
[1]   H. Kim, P. Likhari, D. Parke, P. Statkevich, A. Marco, Ch. Lin, A. A. Nomeir: High-performance liquid chromatographic analysis and stability of anti-tumor agent temozolomide in human plasma; Journal of Pharmaceutical and Biomedical Analysis 24 (2001) 461-468.
[2] Guideline on bioanalytical method validation. European Medicines Agency (EMEA/CHMP/EWP/192217/2009). London, 21 July 2011.
[3]   Guidance for Industry. Bioanalytical Method Validation. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Veterinary Medicine (CVM). May 2001.

• Legal notice:
  

  Copyright (c) Pielaszek Research, all rights reserved.
  The above materials, including auxiliary resources, are subject to Publisher's copyright and the Author(s) intellectual rights. Without limiting Author(s) rights under respective Copyright Transfer Agreement, no part of the above documents may be reproduced without the express written permission of Pielaszek Research, the Publisher. Express permission from the Author(s) is required to use the above materials for academic purposes, such as lectures or scientific presentations.
  In every case, proper references including Author(s) name(s) and URL of this webpage: https://science24.com/paper/28119 must be provided.

1. Optimization of cloud-point extraction method for determination of bisoprolol in human plasma by LC-MS/MS 
2. Validated HPLC-UV method for determination of capecitabine in human plasma
3. Bioequivalence study of ondansetron film-coated tablets in healthy volunteers
4. Development and validation of LC-MS method for determination of lapatinib in human plasma
5. Validated LC-MS/MS method for the complementary determination of free and total genistein in human plasma
6. Comparison of bisoprolol pharmacokinetics after 10 mg oral administration of Bisocard and reference formulation to healthy subjects
7. Bioequivalence study of 500 mg cefuroxime film-coated tablets in healthy volunteers
8. Determination of Sunitinib in human plasma using LC/MS
9. Validation of bioanalytical methods according to new European Medicines Agency guideline
10. Development and validation of a liquid chromatography / single quadrupole mass spectrometry method for the determination of aripiprazole in human plasma
11. LC/MS/MS determination of exemestane in human plasma
12. HPLC determination of cefuroxime in human plasma
13. Application of confidence intervals to bioanalytical method validation
14. LC-MS DETERMINATION OF TAMSULOSIN IN HUMAN PLASMA