Submit Manuscript  

Article Details


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

[ Vol. 16 , Issue. 1 ]

Author(s):

Dharmendra Jayantibhai Prajapati, Usmangani Khalilurraheman Chhalotiya*, Minesh Dahyabhai Prajapati, Jalpa Upendrabhai Patel and Jaineel Vinodrai Desai   Pages 104 - 112 ( 9 )

Abstract:


Objective: An impressionable, discriminatory and precise stability indicating high performance thin layer chromatographic method has been developed and validated for the estimation 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 was 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 27.43 ng/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.

Keywords:

Enzalutamide, forced degradation, HPTLC, validation, anti-cancer drug, TLC method.

Affiliation:

Department of Pharmaceutical Chemistry and Analysis, Indukaka Ipcowala College of Pharmacy, Phase IV, ADIT Campus, New Vallabh Vidyanagar – Gujarat 388121, Department of Pharmaceutical Chemistry and Analysis, Indukaka Ipcowala College of Pharmacy, Phase IV, ADIT Campus, New Vallabh Vidyanagar – Gujarat 388121, Department of Pharmaceutical Chemistry and Analysis, Indukaka Ipcowala College of Pharmacy, Phase IV, ADIT Campus, New Vallabh Vidyanagar – Gujarat 388121, Department of Pharmaceutical Chemistry and Analysis, Indukaka Ipcowala College of Pharmacy, Phase IV, ADIT Campus, New Vallabh Vidyanagar – Gujarat 388121, Department of Pharmaceutical Chemistry and Analysis, Indukaka Ipcowala College of Pharmacy, Phase IV, ADIT Campus, New Vallabh Vidyanagar – Gujarat 388121

Graphical Abstract:



Read Full-Text article