https://ijpbr.in/index.php/IJPBR/issue/feedIndian Journal of Pharmaceutical and Biological Research2025-11-07T06:08:40+00:00Narendra Singheijpbr@gmail.comOpen Journal Systems<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> </p> <p> </p>https://ijpbr.in/index.php/IJPBR/article/view/1112Analytical Method Development and Validation of Selpercatinib in Pure and Pharmaceutical Dosage Form by RP-HPLC2025-11-07T06:08:40+00:00Jonnakuti Madhvilathamadhavilathajonnakuti@gmail.comNarendra Kumar Nyolamadhavilathajonnakuti@gmail.comNiranjan Shishir Mahajanmadhavilathajonnakuti@gmail.com<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 <2%), robustness, and system suitability. The assay of marketed formulations showed 99.68% content, confirming the method’s applicability for routine quality control.</p>2025-06-30T00:00:00+00:00##submission.copyrightStatement##