Indian Journal of Pharmaceutical and Biological Research https://ijpbr.in/index.php/IJPBR <p>Indian Journal of Pharmaceutical and Biological Research (IJPBR) is an open access, international, peer-reviewed, quarterly, indexed scientific journal publishing original research findings and reviews on all aspects of Pharmaceutical and Biological sciences.</p> <p>&nbsp;</p> <p>&nbsp;</p> MRI Publication Pvt. Ltd en-US Indian Journal of Pharmaceutical and Biological Research 2320-9267 Analytical Method Development and Validation of Selpercatinib in Pure and Pharmaceutical Dosage Form by RP-HPLC https://ijpbr.in/index.php/IJPBR/article/view/1112 <p>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 &lt;2%), robustness, and system suitability. The assay of marketed formulations showed 99.68% content, confirming the method’s applicability for routine quality control.</p> Jonnakuti Madhvilatha Narendra Kumar Nyola Niranjan Shishir Mahajan ##submission.copyrightStatement## http://creativecommons.org/licenses/by-nc-nd/4.0 2025-06-30 2025-06-30 13 02 1 7 10.30750/10.30750/ijpbr.13.2.01