Quantification of Newly Discovered Anti-Cancer Drug Enzalutamide in Bulk and Synthetic Mixture by Stability Indicating TLC Method

Abstract

Objective A impressionable, discriminatory and precise stability indicating high performance thin layer chromatographic method has been developed and validated for the estimation of of Enzalutamide in bulk and synthetic mixture. Method The method engaged HPTLC aluminium plates pre-coated with silica gel 60F-254 as the stationary phase while the solvent system was ethyl acetate: toluene (4.5:5.5, v/v). The Rf value of enzalutamide was detected to be 0. 39 ± 0. 005 and the densitometric analysis were carried out in absorbance mode at 246 nm. The linear regression analysis data for the calibration plots presented a virtuous linear relationship for enzalutamide over a concentration range of 20 - 1000ng/band. Results The limit of detection and limit of quantification for enzalutamide was found to be 9.05 and 27.43ng/band. Enzalutamide was imperilled to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photolytic degradation. The degraded product peaks were well resolved from the pure drug peak with substantial difference in their Rf values. Conclusion Stressed samples were assayed using developed TLC technique. Suggested method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of enzalutamide in synthetic mixture.

Characteristics, properties, and analytical and bio‐analytical methods of enzalutamide: A review

“…A stability-indicating HPLC method for ENZ and its impurities in soft gel dosage formulation was reported [26]. TLC technique for quantifying ENZ in bulk drugs and the synthetic mixture was published [27]. The sensitivity of analytical and bio-analytical methods depends on the detector as well as the matrix in the sample.…”