Analytical Method Development and Validation for Determination of Selpercatinib by Using RP-HPLC
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Selpercatinib, Method Development, Validation, ICH guidelines, RP-HPLC, RTKs
Abstract
A novel, specific and precise RP-HPLC method has been developed and validated for the quantification of selpercatinib in pure and its pharmaceutical dosage form. Selpercatinib is a kinase interrupter with increased selectivity for rearranged during transfection (RET) tyrosine kinase receptors (RTKs) above the additional RTK classes. It is used for the treatment of RET fusion positive non-small cell lung carcinoma (NSCLC). The segregation was accomplished on the Zorbax C18 column (150 x 4.6 mm) with a 5 µ particle size. 0.1% orthophosphoric acid and Acetonitrile (ACN) (60:40 v/v) was used as an optimized mobile phase at a flow rate of 1ml/min. The wavelength selected was 220.0nm. The retention time for selpercatinib was 2.653 min. The linearity of selpercatinib was detected to be 5- 30µg/ml. Linearity equations obtained for selpercatinib was y = 18428x + 2196.2 with correlation coefficient 0.999. The % RSD for precision was found to be less than 2%. %Recovery was obtained as 99.74% for selpercatinib. The LOD and LOQ for selpercatinib were obtained as 0.02 µg/ml and 0.05 µg/ml.
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