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> </p> <p> </p>MRI Publication Pvt. Ltden-USIndian Journal of Pharmaceutical and Biological Research2320-9267Analytical 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 <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 MadhvilathaNarendra Kumar NyolaNiranjan Shishir Mahajan
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http://creativecommons.org/licenses/by-nc-nd/4.0
2025-06-302025-06-3013021710.30750/10.30750/ijpbr.13.2.01