A Validated Stability Indicating RP-HPLC Method Development for Anticancer Drug Enzalutamide in Bulk and Pharmaceuticals

B. Anjaneyulu Reddy, P. Radhakrishnanand, Md. Irshad Alam3, P. Ravi Kiran
2019 International Journal of Pharmaceutical Sciences and Drug Research  
A reproducible stability-indicating Reverse Phase-HPLC technique for the quantification of Enzalutamide in in pharmaceuticals was developed and validated. Chromatography was done on Inertsil ODS-C18 5μm (250 mm × 4.6 mm) analytical column with acetonitrile: methanol: water in 40:30:30% v/v proportion as a mobile phase and 1 ml/min as a flow rate. Enzalutamide was detected at 237 nm UV-wavelength maximum. In the present work mobile phase used as diluents, developed technique was validated over
more » ... as validated over 20-150μg/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 findings of 0.53μg/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.
doi:10.25004/ijpsdr.2019.110303 fatcat:5wuf3sbpwjgbblwzdqpulpoel4