Development and Validation of a Stability- Indicating UPLC Method for Assay of Tagoprazon Pharmaceutical Formulations

A simple, rapid, accurate, and stability-indicating Ultra-Performance Liquid Chromatography (UPLC) method was developed and validated for the quantitative determination of Tegoprazan in bulk drug and pharmaceutical tablet formulations. The chromatographic separation was achieved using an Agilent Eclipse Plus C18 column (100mm × 4.6mm, 3.5µm) with a mobile phase consisting of ammonium formate buffer (pH 2.5) and acetonitrile in a 60:40 v/v ratio. The method was operated at a flow rate of 0.5mL/min with an injection volume of 5µL, and detection was performed at 249nm using a Photodiode Array detector. The total run time was 3.0 minutes, and Tegoprazan eluted at a retention time of approximately 1.236 minutes. The method was validated according to ICH Q2(R2) guidelines for specificity, system precision, linearity, accuracy, precision, sensitivity, robustness, and forced degradation studies. The system precision showed excellent reproducibility with a %RSD of 0.68. The method demonstrated excellent linearity over a concentration range of 25-150µg/mL with a correlation coefficient (R²) of 0.99988. Accuracy results ranged from 99.3% to 100.4%, confirming the method's reliability. The limit of detection (LOD) and limit of quantification (LOQ) were determined as 0.30µg/mL and 1.00µg/mL, respectively. Method precision and intermediate precision showed %RSD values of 0.80% and 0.69%, respectively, within the acceptance criteria. Robustness studies confirmed that the method was unaffected by deliberate variations in flow rate and organic phase composition. Forced degradation studies revealed that Tegoprazan was most susceptible to oxidative degradation (14.2%), followed by acid degradation (12.8%), thermal degradation (11.9%), and alkali degradation (9.5%), with minimal degradation under reductive (1.6%) and photolytic (0.9%) conditions. The purity angles were consistently lower than purity thresholds for all degradation conditions, confirming the stabilityindicating nature of the method. The developed method was successfully applied to assay commercial PCAB 50 tablets, showing a mean assay value of 99.2% of the label claim. The method is simple, cost-effective, and suitable for routine quality control and stability analysis of Tegoprazan in pharmaceutical formulations.