Impurity Profiling of Some Anti - Cancer Drugs With Special Reference to Lazertinib

Abstract

A simple, specific, accurate and precise stability-indicating reversed-phase liquid chromatographic method had been developed and validated as per ICH guideline for Estimation of Lazertinib in its pharmaceutical dosage form (Tablet). Also, a forced degradation study of Lazertinib was performed for conditions like acid, alkali, peroxide, reduction, thermal and hydrolysis. The method was based on isocratic elution using a mobile phase mixture as Acetonitrile: 0.1% Formic Acid, pH - 2.25 / OPA (50:50 % v/v) at a flow rate of 1.0 ml/min, with Waters X-Terra RP-18 (150 mm x 4.6 mm, 3.5µm) column. Detection wavelength was 241 nm. In addition, Degradation Products were identified for Acid, Alkali, Peroxide, Reduction and Hydrolysis forced degradation condition as DP – 1, DP - 2, DP - 3, DP – 4 and DP - 5 respectively and were verified by LC – MS/MS. Their Possible degradation pathway were also drawn. Linearity was observed for 20 - 120 μg / ml. For accuracy recovery data the approach was successful because the recuperation values were within the scope. For Precision and Robustness the RSD percentage were determined to be within reasonable limits. It can be successfully adopted for routine quality control analysis of Lazertinib in its pharmaceutical dosage form without any interference. The forced degradation products were identified [M+ H] + ion, and the proposed structures were supported by UPLC–MS/MS experiments combined with correct mass evaluations. The UPLC method was supported as per ICH guidelines and can be applied to the marketed formulations.