AbstractThe present research work focuses on the development and validation of a simple, precise,accurate, economical, and reproducible Reverse Phase High Performance LiquidChromatographic (RP-HPLC) method for the estimation of Enzalutamide in bulk drug andpharmaceutical dosage form. Enzalutamide is a non-steroidal antiandrogen widely used in thetreatment of metastatic castration-resistant prostate cancer. Accurate analytical methods areessential for ensuring the quality, safety, and efficacy of pharmaceutical formulations.Preformulation studies such as solubility analysis, melting point determination, FTIRspectroscopy, and UV spectroscopic studies were carried out for identification andcharacterization of the drug. The λmax of Enzalutamide was found to be 236 nm.Chromatographic separation was achieved using an Inertsil C18 column with a mobile phaseconsisting of Acetonitrile: Phosphate Buffer (65:35, pH 4.5) at a flow rate of 1 ml/min anddetection wavelength of 236 nm. The developed method produced a sharp and symmetricalpeak with retention time around 3.981 minutes.The method was validated according to ICH guidelines for various parameters includingaccuracy, precision, specificity, linearity, ruggedness, robustness, limit of detection (LOD), andlimit of quantitation (LOQ). The calibration curve showed good linearity within the selectedconcentration range with satisfactory correlation coefficient. Recovery studies indicatedexcellent accuracy of the method, while precision studies demonstrated reproducibility ofanalytical results. Low values of LOD and LOQ confirmed sensitivity of the developed method.
Dr. Madhuri A. Theng Nandini P. Khirade (Sat,) studied this question.