An accurate, sensitive, selective and precise stability indicating Isocratic RP-LC method and UVvisible Spectroscopic method were developed for the quantitative determination of enzalutamide in bulk and synthetic mixture. The HPLC was carried out by reversed-phase technique on Sun fire C18, 5 µm column with mobile phase containing methanol: water (70:30). The flow rate was 1.0 ml/min and effluents were monitored at 234 nm with help of photodiode array (PDA) detector. UV spectroscopic determination was carried out at an absorption maximum of 234 nm using methanol as a solvent. The linearities were in the range of 4-14 µg/ml for UV-visible spectroscopic method and 0.03-20 µg/ml for RP-LC method, respectively. Validation of proposed method has been carried out with respect to linearity, accuracy, precision, specificity and robustness. Stock solution of EZA was subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photolytic degradation and quantification has been carried out by proposed RP-LC method. Enzalutamide is susceptible to acidic and basic hydrolysis while it is stable towards chemical oxidation, dry heat and photolytic stress condition. Statistical comparison of both the method has been carried out by Student's F-test showed no significant difference between the results obtained by the two methods. Due to sensitivity, rapidity and accuracy of methods, we believe that the both proposed methods will be useful for the routine quality control analysis and quantification of drug in bulk and from synthetic mixture.
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.
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