Abstrakt

Validated UV Spectroscopic Methods for Determination of Enzalutamide in Pure and Pharmaceutical Dosage Form

Zamir GK, Shwetal SP, Prashant KD and Praveen OP

Two simple, rapid, precise and novel spectrophotometric methods have been developed for the determination of Enzalutamide (EZA) in pure and pharmaceutical dosage form. A novel, non-steroidal antiandrogen agent EZA used in the treatment of metastatic castration resistant prostate cancer. No single UV spectrophotometric method is reported for estimation of EZA. Present study focused on the development of simple spectrophotometric method (Method I) based on the determination of EZA at 236 nm and area under curve (AUC) spectrophotometric method (Method II) involved determination of AUC in between 220.0 nm to 255.0 nm. The drug follows Beer-Lambert’s law in concentration range of 3 μg/mL to 15 μg/mL in solvent methanol (r2=0.999). The methods were validated according to ICH guidelines for accuracy, precision, sensitivity and ruggedness. There was no significant difference between performance of the proposed methods regarding mean values and standard deviation. The percent relative standard deviation was not more than 2%. The proposed method is suitable for routine quality control.