Stability Indicating Isocratic RP-HPLC Method for Simultaneous Estimation of Nivolumab and Relatlimab in Bulk and Pharmaceutical formulation

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Nivolumab and Relatlimab in bulk and pharmaceutical dosage form. Chromatographic separation of Nivolumab and Relatlimab was achieved on Waters Alliance-e2695 by using Phenyl (250x 4.6mm, 5µ) column and the mobile phase containing Acetonitrile: TEA pH-2.5/OPA in the ratio of 50:50% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 222nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Nivolumab and Relatlimab were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Nivolumab and Relatlimab.

Nivolumab, Relatlimab, RP-HPLC, Isocratic

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