Development and Validation of Stability Indicating RP-HPLC Method for Determination of Enzalutamide

DOI:

https://doi.org/10.37285/ijpsn.2019.12.5.3

Authors

  • Pankaj Padmakar Nerkar
  • Sameer Ansari
  • Shailesh Chalikwar

Abstract

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 Dec. 11];12(5):4635-4. Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/315

Issue

Section

Research Articles

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