Development of a Validated RP-HPLC/UV Method for the Quantitative Determination of Tyrosine Kinase RET Inhibitor: Selpercatinib in Capsule Formulation

Abstract

A validated RP-HPLC/UV method was developed to estimate the selpercatinib in capsules. The wavelength chosen for detection was at 248 nm. The RP-HPLC separation was carried out using a Hypersil ODS C18 column (250×4.6 mm, 5 μm) with a mobile phase consisting of 0.2% TFA (pH 6.5) and acetonitrile in a ratio of 70:30 v/v. The flow rate was set at 1 ml/min. The retention time for selpercatinib was determined to be 3.012 min.  Linearity was detected within the concentration range of 2.5-15 μg/mL for selpercatinib. The approach has been confirmed to be linear, accurate, precise, robust, and has established limits of detection and quantitation. The established procedure was uncomplicated, cost-effective, and suitable for the routine analysis of selpercatinib in capsule dosage form. Keywords: Selpercatinib, RP-HPLC and Validation.