Objective This study aims to improve the accuracy and reliability of the determination of active ingredient content in Enteritis Ning Granules by optimizing high-performance liquid chromatography (HPLC) technology, and comprehensively evaluate the uncertainty of the determination results. Methods In this study, the Agilent 1260 HPLC system was used to determine the content of gallic acid active ingredient in Enteritis Ning Granules by optimizing chromatographic conditions such as mobile phase ratio, detection wavelength, column temperature, and solvent. At the same time, establish mathematical models toquantify multiple sources of uncertainty such as instrument errors, operational errors, and sample preparation errors. Results The optimized chromatographic technique significantly improved the sensitivity and accuracy of detecting active ingredients in Enteritis Ning Granules. The content of gallic acid is${27.5}\mathrm{{mg}}$, the chromatographic peak shape is symmetrical, and the separation degree and theoretical plate number have reached the ideallevel. The uncertainty analysis shows that the total uncertainty is small$\left({{U}_{\text{total }}={5.40}\%}\right)$, indicating that the optimized chromatographic technique has high reliability. Conclusion This study successfully optimized the HPLC method for determining the content of Enteritis Ning Granules, and demonstrated the accuracy and reliability of the method through a comprehensive evaluation of uncertainty. This provides a more accurate and reliable analytical method for the quality control of Enteritis Ning Granules, and also offers a new methodology for the modernization analysis of traditional Chinese medicine preparations.

Enteritis Ning Granules  /  high performance liquid chromatography (HPLC)  /  content determination  /  uncertainty analysis  /  quality control of traditional Chinese medicine preparations