A Facile RP-HPLC Method for the Determination of Capmatinib in Human Plasma: Development and Validation

Abstract

A simple, precise, accurate, sensitive, repeatable, and RP-HPLC technique was established and validated for assessing Capmatinib in human plasma. A Hypersil C18 column (250mm 4.6mm; 5 m) was employed for the chromatographic separation. The orthophosphoric acid buffer, methanol, and acetonitrile ratio of the mobile phase has been optimized at a flow rate of 1.0 ml/min. A model UV detector with a variable wavelength was used to measure the detection wave length at 252 nm. Capmatinib (CPTB) and Erlotinib (ETB), which was employed as an internal standard, were perfectly eluted from plasma samples using the liquid-liquid extraction procedure with methanol as the solvent. The CPTB and ETB (IS) retention times using the developed method are determined to be 3.1 and 5.9 min, respectively. The assay shows a linear (r2> 0.99) calibration range over the concentration range of 5-30μg/mL of plasma analyte concentration. This method also demonstrated an intra and inter-day precision within the range of 0.41%-0.86% and 0.44%-0.94%, respectively. The obtained LOQ value was calculated as 5.0μg/mL with precision and accuracy. The mean recovery of CPTB was 98.95%–100.12%.Utilizing human plasma, a simple, rapid, accurate, linear, precise, and robust bio-analytical approach was developed and validated. The method was firmly validated in accordance with ICH recommendations. The results obtained demonstrate that the proposed method can be successfully used for routine Capmatinib analysis in human plasma.