Development & Validation Of RP-HPLC Method For Analytical Evaluation Of Ribociclib In Bulk Drug And Pharmaceutical Dosage Form

Purpose: A new Reverse Phase high-performance liquid chromatography (RP-HPLC) method was developed for the quantitative determination of ribociclib bulk and its tablet dosage form. Method: The chromatographic separation was achieved on Symmetry ODS C18 (4.6×150mm, 5µm). The mobile phase selected was Methanol: Phosphate Buffer pH-4.2 in the ratio of 35:65% v/v at a flow rate of 1ml/min with column temperature maintained at 40°C and 10µl injection volume. The detection was carried out at 276 nm. Results: The retention time of Ribociclib was found to be 3.02 min. The developed HPLC method was validated as per ICH (Q2R1) guidelines. The HPLC method was linear over the range of 10-50µg/ml with a regression coefficient of 0.999.The %recovery for accuracy was found to be 100.1-100.4.The % purity for assay was found to be 99.57%.Conclusion: The developed HPLC method was a simple, sensitive, precise, accurate, robust and economical therefore, it can be applied for routine quality control analysis of Ribociclib in its tablet dosage form.