Development and Validation of Stability Indicating RP-HPLC Method for Determination of Enzalutamide
DOI:
https://doi.org/10.37285/ijpsn.2019.12.5.3Abstract
A simple, isocratic, and accurate reversed phase HPLC method was developed for the quantitative determination of enzalutamide. The chromatographic separation was achieved on an Qualisil BDS C18 (250 mm x 4.6mm, 5 μm) column using methanol: ammonium acetate buffer pH 4.2 adjusted with glacial acetic acid: (60:40, v/v) as a mobile phase, at a flow rate of 1 ml/min and detection at 236nm. The linear range for enzalutamide were 2.0 to 10 μg/mL was obtained with correlation coefficients ≥ 0.998. The retention time was found to be 6.30min. Enzalutamide was subjected to stress conditions hydrolysis (acid, base) oxidation, photolysis and thermal degradation and the stressed samples were analysed by the developed method. The method was validated for the precision, accuracy, linearity and robustness. The developed stability indicating method for enzalutamide was validated as per ICH guidelines.
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Keywords:
Enzalutamide, RP-HPLC method, Stability indicating method, Validation, ICH
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Published
2019-09-30
How to Cite
1.
Nerkar PP, Ansari S, Chalikwar S. Development and Validation of Stability Indicating RP-HPLC Method for Determination of Enzalutamide. Scopus Indexed [Internet]. 2019 Sep. 30 [cited 2024 Sep. 8];12(5):4635-4. Available from: http://ijpsnonline.com/index.php/ijpsn/article/view/315
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Research Articles
References
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van Nuland M, Venekamp N, Wouters WM, van Rossum HH, Rosing H, Beijnen JH. (2019). LC-MS/MS assay for the quantification of testosterone, dihydrotestosterone, androstenedione, cortisol and prednisone in plasma from castrated prostate cancer patients treated with abiraterone acetate or enzalutamide. J Pharm and Biom Analy 13: 66-72.
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Bennett LL and Ingason A (2014). Enzalutamide (Xtandi) for patients with metastatic, resistant prostate cancer. Anals of Pharm ther 48: 530-7.
Blessy MR, Patel RD, Prajapati PN and Agrawal YK (2014). Development of forced degradation and stability indicating studies of drugs—A review. J pharm Ana 4(3): 159-65.
Cione AP, Tonhi E and Silva P (2011). Stability indicating methods. Q C of Herbal Medicines and Related Areas. In Tech, 25e36.
Kim KP, Parise RA, Holleran JL, Lewis LD, Appleman L, van Erp N, Morris MJ and Beumer JH (2017). Simultaneous quantitation of abiraterone, enzalutamide, N-desmethyl enzalutamide, and bicalutamide in human plasma by LC–MS/MS. J Pharml and Biom ana. 138: 197-205.
Ou S (2016). Design and synthesis of enzalutamide-isothiocyanate hybrid drug as anti-prostate cancer agent. Wayne State University.
Patel Riddhiben M, Patel Piyushbhai M and Patel Natubhai M (2011). Stability indicating HPLC method development-A review. Inter Res J Pharmacy 3: 32-43.
Puszkiel A, Plé A, Huillard O, Noé G, Thibault C, Oudard S, Goldwasser F, Vidal M, Alexandre J and Blanchet B (2017). A simple HPLC-UV method for quantification of enzalutamide and its active metabolite N-desmethyl enzalutamide in patients with metastatic castration-resistant prostate cancer. J Chrom B. 15: 1058: 102-7.
Rawat T and Pandey IP (2015). Forced degradation studies for drug substances and drug products-scientific and regulatory considerations. J pharm Sci and Res 7(5):238.
Skoog D, West D, Holler F and Crouch S (2013). Fundamentals of Analytical Chemistry. Nelson Education, pp1-5.
Snyder L R, Kirkland J J and Glajch J L (2012). Practical HPLC Method Development, John Wiley & Sons.
Srivastava M (2010). High-Performance Thin Layer Chromato-graphy. Springer pp-19-95.
Townshend A (2014). Introduction to ANCR–Analytical Chemistry Research. Ana Chem Res 1: 22.
van Nuland M, Venekamp N, Wouters WM, van Rossum HH, Rosing H, Beijnen JH. (2019). LC-MS/MS assay for the quantification of testosterone, dihydrotestosterone, androstenedione, cortisol and prednisone in plasma from castrated prostate cancer patients treated with abiraterone acetate or enzalutamide. J Pharm and Biom Analy 13: 66-72.
Venkataraman S and Manasa M (2018). Forced degradation studies: Regulatory guidance, characterization of drugs, and their degradation products-A review. Drug Invention Today. 10(2): 33-38.
World Health Organization (2006). Stability testing of active substances and pharmaceutical products. Working document QAS/06, 179: 1-33.
Wu H, Zhang L, Gao X, Zhang X, Duan J, You L, Cheng Y, Bian J, Zhu Q and Yang Y (2017). Combination of sorafenib and enzalutamide as a potential new approach for the treatment of castration-resistant prostate cancer. Cancer Letters 385: 108-116.
Zhou AN, Li B, Ruan L, Wang Y, Duan G and Li J (2017). An improved and practical route for the synthesis of enzalutamide and potential impurities study. Chinese Chem Letters 28(2): 426-30.
