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Published on:April 2017
Indian Journal of Pharmaceutical Education and Research, 2017; 51(2s):s61-s68
Original Article | doi:10.5530/ijper.51.2s.51

Development of Stability Indicating TLCDensitometry Method of Edaravone Using QbD Approach: Degradation Kinetic Study


Authors and affiliation (s):

Madhuri Baghel1, Sadhana Rajput2*

1Centre of Relevance ad Excellence in Novel Drug Delivery Systems, Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara- 390002, Gujarat, India.

2Centre of Relevance and Excellence in Novel Drug Delivery System, Faculty of Pharmacy, G. H. Patel Building, Donor’s Plaza, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara – 390002, Gujarat, INDIA.

Abstract:

Objective: The objective of present method was to utilize risk based and systematic Quality by design approach for development of selective, sensitive, precise, accurate and robust stability-indicating TLC-densitometry for quantification of Edaravone and its degradation products. Method: The TLC-densitometric analysis was carried out in the absorbance mode at 244 nm using solvent system petroleum ether: ethyl acetate: glacial acetic acid (6ml:4ml:10μl v/v/v). This system was found to give compact and well resolved spot for Edaravone at an Rf value of 0.46 ± 0.21. Results: Edaravone undergoes significant degradation when subjected to stress degradation in acid, base, neutral, oxidative, photolytic, dry heat induced and accelerated humidity/temperature degradation conditions. The method was validated according to ICH guideline. Linearity was found in the range of 04-24 μg/band. The LOD and LOQ for Edaravone were 0.327μg/band and 0.989μg/band respectively. No interference was observed from excipients in formulation as well as degradation product, indicating specificity of the method. Moreover, the proposed method was also utilized to investigate the kinetics of acid, base, neutral and oxidative degradation process at different concentrations and temperatures. The kinetics of degradation profile was determined using linear and nonlinear regression analysis. The rate constants and half-life were calculated.

Key words: Edaravone, CNX approach, QbD, SIAMs, TLC-densitometry. 

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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