A simple, stability indicating,selective, reproducible, economic, selective,RP- HPLC method has been developed and validated as per ICH guidelines for the estimation of Ceritinib (CER) both in bulk drug and in capsule dosage forms in the presence of degradation products. Reversed-phase chromatography was performed on a Kromosil C18 column with mobile phase Methanol: water (65:35 v/v) at a flow rate of 1.0 ml min-1. Detection was performed at 265nm and a sharp peak was obtained for CER at a retention time of 2.585 min. The method was validated for, precision, specificity and selectivity, accuracy, robustness, detection and quantification limits, and system suitability in accordance with ICH guidelines. Linear regression analysis data for the calibration plot showed there was a good linear relationship between response and concentration in the range 30- 150 ppm; the regression coefficient was 0.998 and the detection (LOD) and quantification (LOQ) limits were found to be 2.97 and 9.92 μg/ ml-1, respectively. Statistical analysis had proved the method was precise, reproducible, selective, specific, and accurate for analysis of CER. In order to determine whether the analytical method and assay were stability-indicating, CER was stressed under various conditions to conduct forced degradation studies. stability indicating forced degradation established studies show results that there is no interference of any degraded products or external environmental conditions and it did not interfere with the detection of CER and the performed assay is thus specific stabilityindicating . The wide linearity range, sensitivity, accuracy, short retention time, and simple mobile phase imply the method is suitable for routine quantification of CER with high precision and accuracy.
