Method Development And Validation For Estimation Of Related Substances In Selpercatinib Bulk Dosage Form By Rp-Hplc Technique

This study focuses on the development and validation of a high-performance liquid chromatography (HPLC) method for the quantification of process-related impurities (Impurity A and Impurity B) in Selpercatinib. The optimized chromatographic conditions employed a gradient-mode HPLC-PDA system using an Inertsil C18 column (250 × 4.6 mm, 5 μm). The mobile phase consisted of sodium dihydrogen phosphate buffer (NaH₂PO₄) adjusted to pH 4, combined with methanol. The flow rate was maintained at 1.0 mL/min, and detection was carried out at 238 nm. The method was validated in accordance with standard parameters including linearity, precision, accuracy, robustness, and forced degradation studies. Linearity demonstrated excellent correlation coefficients (r² > 0.999) across the specified concentration ranges. Precision studies showed low variability, with %RSD values below 2%, confirming the method’s reproducibility. Accuracy results indicated satisfactory recovery, ranging from 98–102% for Selpercatinib and 90–110% for the impurities, demonstrating the method’s reliability in quantification. Degradation studies further confirmed the stability-indicating capability of the method, supporting its suitability for routine quality control and stability assessment. Overall, the developed method provides a robust, precise, and reliable analytical approach for ensuring the purity of Selpercatinib and compliance with regulatory requirements in pharmaceutical analysis.

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