Development and Validation of a Stability-Indicating RPHPLC Method for the Quantitative Determination of Tegoprazan in Bulk Drug and Pharmaceutical Dosage Forms
Abstract
Objective: The current study objective was to develop and validate a simple, rapid, and stability-indicating RP-HPLC method for the quantitative determination of tegoprazan in bulk drug and pharmaceutical formulations.
Materials & Methods: The chromatographic separation was achieved on Waters XBridge C18 column (250 × 4.6 mm, 5 μm) using acetonitrile and 0.02 M potassium dihydrogen phosphate buffer (60:40, v/v) adjusted to pH 5.2 at 1.0 mL/min as mobile phase. Detection was carried out at 303 nm with a total run time of 6 min. In the optimized conditions, tegoprazan display sharp and symmetrical peak at a retention time of approximately 2.5 min.
Results: The developed method produces excellent linearity over 10–60 μg/mL with a regression coefficient (R²) of 0.9994. The limits of detection (LOD) and quantification (LOQ) were noticed to be 0.03 μg/mL and 0.10 μg/mL, respectively indicates high sensitivity of the method. Precision studies produce %RSD values of <2%, proves good repeatability and intermediate precision. Accuracy assessed by recovery studies at 50%, 100%, and 150% levels yields recoveries between 98.30% and 101.11%. Robustness evaluation demonstrates minimal variation (<2%) upon small deliberate changes in chromatographic parameters. The forced degradation studies reveal that tegoprazan was most susceptible to acidic conditions and display good stability under oxidative, thermal, and photolytic stress. The method was successfully applied to the analysis of a commercial formulation with an assay value of 99.52%.
Conclusion: The developed method was simple, accurate, precise, and stability-indicating and suitable for routine quality control as well as stability analysis of tegoprazan in bulk drug and pharmaceutical dosage forms.
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