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

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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.

Medienart:

E-Artikel

Erscheinungsjahr:

2019

Erschienen:

2019

Enthalten in:

Zur Gesamtaufnahme - volume:16

Enthalten in:

Current drug discovery technologies - 16(2019), 1 vom: 27., Seite 104-112

Sprache:

Englisch

Beteiligte Personen:

Prajapati, Dharmendra Jayantibhai [VerfasserIn]
Chhalotiya, Usmangani Khalilurraheman [VerfasserIn]
Prajapati, Minesh Dahyabhai [VerfasserIn]
Patel, Jalpa Upendrabhai [VerfasserIn]
Desai, Jaineel Vinodrai [VerfasserIn]

Links:

Volltext

Themen:

2010-15-3
55X04QC32I
93T0T9GKNU
Anti-cancer drug
Antineoplastic Agents
Benzamides
Enzalutamide
Forced degradation
HPTLC
Hydrochloric Acid
Journal Article
Nitriles
Phenylthiohydantoin
QTT17582CB
Sodium Hydroxide
TLC method
Validation.

Anmerkungen:

Date Completed 08.07.2020

Date Revised 04.12.2021

published: Print

Citation Status MEDLINE

doi:

10.2174/1570163814666171027120238

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM277442583