Author:
Khan Z. G,Patil S. S.,Deshmukh P. K.,Patil P. O.,
Abstract
Novel, isocratic reversed phase high performance liquid chromatography method was developed and validated for the determination of enzalutamide (EZA) in bulk drug and pharmaceutical formulation. Efficient separation was achieved on PrincetonSPHER C18 100A, 5μ (250×4.6 mm) under the isocratic mode of elution using acetonitrile: water (80:20) % V/V as a mobile phase pumped in to the column at flow rate 1.0 mL/min. The effluent was monitored at 237.0 nm using UV detector. EZA was eluted in the given mobile phase at retention time (tR) of 3.2 minutes. The standard calibration curve was linear over the concentration range 10 - 60 μg/mL with correlation coefficient 0.997. The method was validated for accuracy, precision, sensitivity, robustness, ruggedness and all the resulting data treated statistically. The system suitability parameters like retention time, theoretical plates, tailing factor, capacity factor were found within the limit.
Publisher
Indian Drug Manufacturers' Association (IDMA)
Subject
Drug Discovery,Pharmaceutical Science,Pharmacology
Reference10 articles.
1. [1] Siddiqui M. R., Alothman Z. A., Rahman N.: Analytical techniques in pharmaceutical analysis: A review, Arab. J. Chem., 2013, 04, 16.
2. [2] Bahl A., Masson S., Birtle A., Chowdhury S., de Bono J.: Second-line treatment options in metastatic castration-resistant prostate cancer: a comparison of key trials with recently approved agents., Cancer Treat. Rev., 2014, 40, 170–7.
3. [3] Bambury R.M., Scher H.I.: Enzalutamide: Development from bench to bedside., Urol. Oncol., 2015, 33, 280–8.
4. [4] Poon D.M.C., Ng J., Chan K.: Importance of cycles of chemotherapy and postdocetaxel novel therapies in metastatic castration-resistant prostate cancer., Prostate Int. 2015, 3, 51–5.
5. [5] D. Evaluation, CENTER FOR DRUG EVALUATION
Cited by
6 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