Identification of Impurities in the Drug Risankizumab Using RP-HPLC Method
Author(s): U. Harini*
Abstract
Aim: To establish and validate a stability-indicating RP-HPLC method for the concurrent quantification of Risankizumab and its associated impurities in both bulk drug substances and pharmaceutical dosage forms.
Specific objectives:
• To develop a simple, rapid and specific RP-HPLC method for the estimation of Risankizumab and its impurities in bulk and combined pharmaceutical dosage forms.
• To validate the proposed methods in accordance with the analytical parameters mentioned in the ICH guidelines, such as system suitability, accuracy, precision, specificity, linearity, robustness, LOD and LOQ.
• To develop the method under the forced conditions such as acid, alkali, peroxide, reduction, thermal, hydrolysis and photo degradation.
A simple, rapid, precise, sensitive and reproducible Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the quantitative analysis of Risankizumab and its impurities in pharmaceutical dosage form. Chromatographic separation of Risankizumab and its impurities was achieved on waters alliance-e2695, by using Luna Phenyl Hexyl 150 mm × 4.6 mm, 5 µ column and the mobile phase containing 0.1% TEA pH-2.5/OPA and Acetonitrile in the ratio of 80:20% v/v. The flow rate was 1 ml/min; detection was carried out by absorption at 263 nm using a photodiode array detector at ambient temperature. The number of theoretical plates for Risankizumab and its impurities was not less than 2000 and the tailing factor did not exceed 2. The % Relative Standard Deviation (%RSD) of peak areas across all measurements remained below 2.0. The developed method was validated in accordance with ICH guidelines. It proved to be a simple, cost-effective, precise, accurate, robust and suitable approach for the quantitative determination of Risankizumab and its impurities, as well as for conducting stability studies.