Development And Validation Of Stability Indicating RP-HPLC Method For Determination Of Ceritinib (original) (raw)

2018, INDONESIAN JOURNAL OF PHARMACY

The purpose of the present work was to develop new, simple, specific, accurate and precise stability indicating RP-HPLC method for determination of ceritinib. In the present study, stress testing of ceritinib was carried out according to ICH guidelines Q1A (R2). ceritinib was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Extensive degradation was found to occur in acidic condition. Mild degradation was observed in basic and at thermal conditions. Successful separation of drug from degradation products formed under stress conditions was achieved on a Hypersil BDS C18 column (250×4.6mm, 5.0μ particle size) using acetonitrile: acetate buffer (pH 3.7±0.05) (50:50 v/v), at a flow rate of 1.0mL/min and column was maintained at 40°C. Quantification and linearity were achieved at 272nm over the concentration range of 5-100μg/mL for ceritinib. The Correlation Coefficient was found to be 0.9960. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness. The developed method will be useful for routine analysis for samples of stability studies in the formulation and development.

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