A VALIDATED STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT FOR ANTI CANCER DRUG ENZALUTAMIDE IN BULK AND PHARMACEUTICALS
Journal Title: International Journal of Pharmaceutical Sciences and Drug Research - Year 2019, Vol 11, Issue 3
Abstract
A reproducible stability-indicating Reverse Phase-HPLC technique for the quantification of enzalutamide in in pharmaceuticals was developed and validated. Chromatography was achieved on Inertsil-ODS-C18 (250mm×4.6 mm) 5µmanalytical column with acetonitrile: methanol: water in 40:30:30% v/v proportion as mobile phase and flow rate of 1 ml/min. Enzalutamide was detected at 237 nm UV-wavelength maximum. In the present work mobile phase used as a diluent. Developed technique was validated over 20-150 µg/ml linear concentration range for enzalutamide. This method established with linearity coefficient value of 0.99 and the percentage recovery was found to be 99.3%. This method was proven with LOD and LOQ values of 0.53 µg/mL and 1.61µg/ml respectively. The drug was degraded in acid and alkaline conditions and the percentage degradation values were 3.10 % and 4.54 % respectively. There was no degradation of drug when exposed to neutral, UV, thermal, sun-light and oxidative conditions.Drug was undergoing degradation when exposed to acid and alkaline conditions. The developed technique was useful in the routine quantitation of enzalutamide.
Authors and Affiliations
B. Anjaneyulu Reddy, P. Radhakrishnanand, Md. Irshad Alam
Keywords
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- EP ID EP622284
- DOI 10.25004/IJPSDR.2019.110303
- Views 66
- Downloads 0
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