Articles Accepted

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR CERITINIB IN BULK AND FORMULATION
by Dr. Santosh Gandhi, 11 Jul 2022
Co-Author(s): Shivani Rajendra Sawarkar,Mrinalini C Damle

Ceritinib is an anti-cancer class of drug used in treatment of non-small cell lung cancer. A simple, selective and precise stability indicating High Performance Thin Layer Chromatography (HPTLC) method has been established for Ceritinib. The stationary phase used was aluminum-backed silica gel60 F254 plates with Chloroform: Methanol: Glacial acetic acid as a mobile phase in the ratio of 8.5:1.5:0.5(v/v/v). The retardation factor was found to be 0.34 ± 0.02. The Densitometric scanning was performed at 277 nm. The linear range for analysis was 100–600 ng band-1 which gives good linear relationship with regression coefficient of 0.9987. The accuracy of the method was determined by the recovery studies. The LOD and LOQ were 7.38 and 10.03 ng band-1, respectively. Stress degradation conditions like hydrolysis under different pH conditions, photolytic, thermal and oxidative degradation was performed as per ICH Q1A(R2) and Q1B guidelines. The method established was found to be robust and thus it can be used as a stability-indicating method

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