DEVELOPMENT OF STABILITY INDICATING NEW ANALYTICAL RP-HPLC METHOD AND VALIDATION FOR THE DETERMINATION OF RIBOCICLIB IN BULK FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM

Nerella Naveen Kumar* and Naveen Kumar Singhal

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the measurement of Ribociclib in active pharmaceutical ingredient and Marketed Pharmaceutical Dosage form of Ribociclib. Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Ribociclib. The chromatographic strategy utilized Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5μm, using isocratic elution with a mobile phase of Phosphate Buffer (0.02M) and Acetonitrile were consists of 48:52% v/v (pH-2.80). A flow rate of 1.0 ml/min and a detector wavelength of 248 nm utilizing the UV detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines. Results: LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range. Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drug.