Development and Validation of a Stability Indicating Ultra‐High‐Performance Liquid Chromatography Method for Simultaneous Determination of Tofacitinib and Its Related Substances in Solid Dosage Forms

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Discussion

This analytical method quantifies tofacitinib and its impurities in solid dosage forms, indicating strong stability and accuracy.

The method enables rapid and simultaneous quantification of tofacitinib and its impurities without complex preparation.
Key findings show linearity for tofacitinib and its related substances with high r2 values, supporting accurate measurements.
Validation confirmed sensitivity and selectivity of the method under various stress conditions, enhancing its reliability.
This approach may facilitate quality control in pharmaceuticals, ensuring accurate dosing and safety for solid dosage pharmaceuticals.

Ergün et al. (2025) studied this question.

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