A New Stability Indicating Method Development And Validation Report For The Assay Of Nivolumab By Rp- Uplc

Abstract

The objective of this study was pointed at developing and progressively validating novel, easy, responsive and stable RP-UPLC Method for the measurement of active pharmaceutical ingredient and their related substances.
Materials and procedures: On a BEH Water 2.1 *50mm, 1.7-micron UPLC Column. the separation was conducted using the mobile phase including a mixture of 0.1% of OPA Buffer: Acetonitrile (30:70) ratio was selected for the study of liquid chromatographic method with flow rate 0.25 ml/min the PDA detection was carried at 281nm.
Results:the nivolumab elution time was achieved on isocratic mode using BEH Water 2.1 *50mm, 1.7-micron UPLC Column. Beer- Lambert’s law was obeyed over a concentration range 10µg/ml and the linear regression equation was Y=0.0489 X+ 0.003 with correlation coefficient 0.999]. the LOD and LOQ was found to be 0.509 and 0.612 µg/ml. Injection volume is 5µl and run time was found to be 3 min. Stress degradation studies such as acidic hydrolysis, alkaline hydrolysis, oxidation and thermal degradation and photo degradation were performed. The method was validated for the parameter’s linearity, precision, accuracy, robustness, LOD and LOQ as per the ICH Guidelines, and nivolumab percentage mean recovery of 99.69 percent.
Conclusion:a new proposed stability indicating liquid chromatographic method was found to be very easy, accurate, precise and robust and can be applied for the assay of Nivolumab formulations therapy.