DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR DETERMINATION OF CERITINIB IN RABBIT PLASMA USING PDA DETECTOR

A rapid, sensitive and reproducible HPLC method was developed and validated for the quantification of Ceritinib in rabbit plasma using PDA detector at wave length 264 nm. The method was developed using Dasatinib as internal standard (IS). Ceritinib is a selective and potent inhibitor of anaplastic lymphoma kinase (ALK) indicated in the treatment of non-small cell lung cancer (NSCLC). The Ceritinib and Dasatinib were separated as symmetrical peaks on an analytical column ODS (250 × 4.6 mm, 5 µm) column using a mixture of 75% phosphate buffer (pH 3.6) and 25% acetonitrile as mobile phase with a flow rate of 1.0 ml/min. The total chromatographic run time is 10.0 min with retention times for Ceritinib and Dasatinib at 7.630 min and 2.771 min respectively, no interferences from the endogenous plasma peaks is observed. The method is validated and linear calibration curves were obtained across a range of 0.002 – 0.2 µg/ml for Ceritinib with a correlation coefficient of 0.999. The coefficients of variation for intra-day and inter-day assays were less than 10%. The intra-batch and inter-batch precision (% CV) across five levels (LLOQ, LQC, MQC, HQC, and ULOQ) is less than 11.15. The method was validated as per the USFDA guidelines and the results were within the acceptance criteria for selectivity, sensitivity, linearity, precision, accuracy, recovery stability of solution and stability of solution in plasma.