Analytical Method Development and Validation of Selpercatinib in Pure and Pharmaceutical Dosage Form by RP-HPLC

Abstract

A robust and sensitive reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of Selpercatinib in pure and pharmaceutical formulations. The method uses a C18 column with a mobile phase of 0.2% trifluoroacetic acid (TFA) and acetonitrile (50:50 v/v) at pH 6.5, detected at 240 nm. Method validation as per ICH Q2 (R1) guidelines demonstrated specificity, linearity (2–10 μg/ml, r²=0.9995), accuracy (mean recovery 100.61%), precision (%RSD <2%), robustness, and system suitability. The assay of marketed formulations showed 99.68% content, confirming the method’s applicability for routine quality control.