Validation of a method for quantifying enzalutamide and its major metabolites in human plasma by LC

Validation of a method for quantifying enzalutamide and its major metabolites in human plasma by LC–MS/MS

Published:2014-03 Issue:6 Volume:6 Page:737-744
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Bennett Daniel¹,Gibbons Jacqueline A²,Mol Roelof³,Ohtsu Yoshiaki⁴,Williard Clark¹

Affiliation:

1. inVentiv Health Clinical Lab, Inc, 301D College Road East, Princeton, NJ 08540, USA

2. Medivation, Inc., 525 Market Street, 36th Floor, San Francisco, CA 94105, USA

3. Astellas Pharma Europe B.V., Sylviusweg 62, PO Box 344, 2300 AH Leiden, The Netherlands

4. Astellas Pharma Inc. 2-1-6, Kashima,Yodogawa-ku, Osaka 532-8514, Japan

Abstract

Background: Enzalutamide is an androgen receptor inhibitor that targets multiple steps in the androgen receptor signaling pathway. Oral enzalutamide was recently approved by the US FDA and health authorities in other regions for the treatment of patients with metastatic castration-resistant prostate cancer who previously received docetaxel. The objective of this study was to validate a method for quantification of enzalutamide and its two major metabolites in human plasma. Results: The analytes were extracted from plasma by an LLE procedure, separated by reversed phase HPLC and detected by MS/MS in positive mode ESI. The quantitation range was 0.0200–50.0 µg/ml. Conclusion: The method proved to be rapid and simple, and met FDA validation criteria.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio.13.325

Reference7 articles.

1. Development of a Second-Generation Antiandrogen for Treatment of Advanced Prostate Cancer

2. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy

3. Antitumour activity of MDV3100 in castration-resistant prostate cancer: a phase 1–2 study

4. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research, Center for Veterinary Medicine.Guidance for Industry Bioanalytical Method Validation.Center for Drug Evaluation and Research, Rockville, MD, USA (2001).

5. Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays

Cited by 28 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. New-generation androgen receptor signaling inhibitors (ARSIs) in metastatic hormone-sensitive prostate cancer (mHSPC): pharmacokinetics, drug-drug interactions (DDIs), and clinical impact;Expert Opinion on Drug Metabolism & Toxicology;2024-05-22

2. Development, Optimization, and Validation of HPLC Method for Quantification of Enzalutamide in Bulk and Pharmaceuticals;Pharmaceutical Chemistry Journal;2023-06

3. Characteristics, properties, and analytical and bio‐analytical methods of enzalutamide: A review;SEPARATION SCIENCE PLUS;2023-02-07

4. A comparative study on in vitro and in vivo characteristics of enzalutamide nanocrystals versus amorphous solid dispersions and a better prediction for bioavailability based on “spring-parachute” model;International Journal of Pharmaceutics;2022-11

5. Computational design and fabrication of a highly selective and sensitive molecularly imprinted electrochemical sensor for the detection of enzalutamide;Journal of Electroanalytical Chemistry;2022-02