Chemometrics‐assisted development of a liquid chromatography method for estimation of lapatinib in tablets: A case study on a novel quality concept

Abstract

AbstractA new validated liquid chromatography method was developed based on the chemometric principles involving quality risk management and design of experiments for estimation of anticancer agent lapatinib. Also, the current research work envisions providing a case study for a novel quality concept. Risk management tools such as fishbone diagram, risk estimation and risk scoring were utilized to derive critical to quality method variables viz. methanol%, flow rate and mobile phase pH. Influence of these variables was studied on critical analytical attributes such as analyte retention, plate count and peak tailing. In addition to the above approaches, the Monte Carlo simulation was applied to assess the procedure performance capability. The optimized chromatographic conditions used methanol: 0.01 M KH2PO4 (80:20, v/v) of pH 7. A flow rate of 1.0 mL/min and detection at 331 nm using a diode array detector provided elution of the analyte at 3.5 min. The method validation results were acceptable for parameters such as linearity (1–160 μg/mL), accuracy (99.85–100.8%), precision (< 1%), limit of detection and limit of quantification. In a nutshell, the novel concept was found befitting for robust and reliable analysis of lapatinib in its pharmaceutical dosage form.