RP-HPLC Method Development and Validation for Estimation of Nivolumab in Marketed Formulations

M.  Maithani; D.  Dwivedi; V.  Rawat

doi:10.32553/jbpr.v11i5.926

M. Maithani Multidisciplinary Research Unit, Veer Chandra Singh Garhwali Government Institute of Medical Science and Research, Srinagar, Pauri Garhwal, India
D. Dwivedi Multidisciplinary Research Unit, Veer Chandra Singh Garhwali Government Institute of Medical Science and Research, Srinagar, Pauri Garhwal, India
V. Rawat Multidisciplinary Research Unit, Veer Chandra Singh Garhwali Government Institute of Medical Science and Research, Srinagar, Pauri Garhwal, India

DOI: https://doi.org/10.32553/jbpr.v11i5.926

Abstract

A simple and precise RP-HPLC method for the estimation of Nivolumab in marketed dosage forms was developed and validated. The chromatographic separation of the drug was done with a Waters Sun Fire C8 Column (250 mm × 4.6 mm i.d., particle size 5 μ) using 0.3% TFA, acetonitrile and methanol (45:35:20 v/v/v) as a mobile phase. The instrument was set at flow rate of 1.2 mLmin^-1 at ambient temperature and the wavelength of UV-visible detector was 230nm. The method showed excellent linearity over a range of 10-250 μgmL^-1for the drug. The correlation coefficient for Nivolumab was noted to be 0.9998. The mean recovery values were found to be 99.38% and 99.90%. The results suggest that the proposed method could be suitable for quantitative determination of Nivolumab in pharmaceutical preparations and also for quality control in bulk manufacturing. The f-test and t-test at 95% confidence level were applied on data for statistical analysis.