AN INNOVATIVE STABILITY INDICATING HPLC METHOD WITH IMPURITY PROFILING OF NIRAPARIB-AN ANTICANCER DRUG IN PHARMACEUTICAL FORMULATIONS

Abstract

A novel and sensitive HPLC method has been developed, and subsequently validated for the analysis of Niraparib and its impurity 1, Impurity 1 Acyl Glucuronide, and impurity 2 in formulations. The separation of Niraparib and its impurities was achieved on Inertsil 3V ODS (250mm × 4.6mm, 5μm) as stationary phase, methanol, 20mM ammonium formate and 0.05% of triethylamine in 80:15:5 (V/V) at pH 5.5 (adjusted with formic acid) at 1.0 mL/min isocratic flow and 246 nm wavelength. In the optimized conditions, the retention time was observed at 8.10, 11.01, 13.50, and 5.18 min respectively for Niraparib, impurity 1, Impurity 1 Acyl Glucuronide, and impurity 2. The method was confirmed to be sensitive with a detection limit of 0.015, 0.045, and 0.024 µg/mL for impurity 1, Impurity 1 Acyl Glucuronide, and impurity 2 respectively. Good linear correlation was observed in the concentration level of 15–120 µg/mL for Niraparib and 0.15 – 1.20 µg/mL for the impurities studied. Stress degradation studies were carried for evaluating the effectiveness of the method for the separation of stress degradation compounds along with known impurities. based on the results, it can be confirmed that the method was stable that can resolve the degradation compounds and the analytes in the study. The % degradation of Niraparib was confirmed to be less than 10% in all the stress degradation conditions studied. Hence the method can effectively be utilized for the routine analysis of Niraparib and its impurity 1, Impurity 1 Acyl Glucuronide, and impurity 2 in the formulation as well as stability studies.