Abstract :
Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive and stable RP-HPLC method for the Quantitative Determination of Nivolumab in active pharmaceutical ingredient and Marketed Pharmaceutical Dosage form. Methods: A simple, selective, validated and well-defined stability that shows isocratic RP-HPLC methodology for the quantitative determination of Nivolumab. The chromatographic strategy utilized Symmetry C18, 250 mm x 4.6 mm i.d.5µm particle size, using isocratic elution with a mobile phase consists of Methanol and Phosphate Buffer (0.02M) (pH-3.8) was taken in the ratio of 70: 30% v/v. A flow rate of 1.0 ml/min and a detector wavelength of 245nm 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 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 drugs.
Keyword :
Nivolumab, RP-HPLC, Method Development, Validation, Accuracy, Precision.