Indian Journal of Pharmaceutical Education and Research | Vol 51 | Issue 2S | Apr-Jun (Suppl), 2017 S61 Original Artcle www.ijper.org Development of Stability Indicating TLC- Densitometry Method of Edaravone Using QbD Approach: Degradation Kinetic Study Madhuri Baghel 1 , Sadhana Rajput 2* 1 Centre of Relevance ad Excellence in Novel Drug Delivery Systems, Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Vadodara- 390002, Gujarat, INDIA. 2 Centre 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 quantifcation 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 signifcant 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 specifcity 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 profle 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. DOI: 10.5530/ijper.51.2s.51 Correspondence: Sadhana Rajput, Quality Assurance Labora- tory, Centre of Relevance and Excellence in Novel Drug Delivery System, Fac- ulty of Pharmacy, G. H. Patel Building, Donor’s Plaza, The Maharaja Sayajirao Univer- sity of Baroda, Fatehgunj, Vadodara – 390002, Gujarat, INDIA. Phone: 02652750605 E-mail: sjrajput@gmail.com INTRODUCTION Edaravone (EDA, Radicut®, MCI-186, developed by Mitsubishi Tanabe Pharma Corporation, Osaka, Japan) has wide thera- peutic time window. 1 EDA (3-methyl-1-phe- nyl-2-pyrazolin-5-one) is neuroprotective agent that has been widely used for the treat- ment of acute embolic stroke in Japan since 2001. 2 This compound possesses potent free radical scavenging and antioxidant actions by inhibiting hydroxyl radical depen- dent and independent lipid peroxidation. 3,4 Unlike other free radical scavengers, EDA (Figure 1) readily crosses the blood–brain barrier. 5 Previously, it was reported that zEDA may be potentially useful in preven- tion of many diseases occurred by ROS. 6,7 Submission Date: 01-12-2016; Revision Date: 03-01-2017; Accepted Date: 15-02-2017 Some methods have been reported for esti- mation of EDA. These include UV spectro- photometric, 8 fuorescent assay, 9 HPLC, 10-12 HPTLC 13 and LC-MS/MS. 14 The HPTLC method was developed for in vitro Estima- tion of EDA in human plasma 13 and to the best of our knowledge no Stability indicat- ing assay method have ever been reported. Hence the aim of present study was to develop stability indicating TLC-densitom- etry method for quantifcation of EDA and its degradation products (DPs) by imple- menting systematic QbD approach and to investigate the kinetics of degradation.