高效液相色谱法在肠炎宁颗粒中活性成分含量测定的优化策略及不确定度评估  

Optimization strategies and uncertainty assessment of high performance liquid chromatography method for determination of active components in Enteritis Ning Granules

作　　者：王雪芹 WANG Xue-Qin(Hainan Inspection and Testing Research Institute,Haikou 570000,China)

机构地区：[1]海南省检验检测研究院,海口570000

出　　处：《实验室检测》2024年第11期131-134,共4页Laboratory Testing

摘　　要：目的本研究旨在通过优化高效液相色谱(HPLC)技术,提高肠炎宁颗粒中活性成分含量测定的准确性和可靠性,并全面评估测定结果的不确定度。方法本研究采用Agilent 1260 HPLC系统,通过优化色谱条件如流动相比例、检测波长、色谱柱温度和溶剂等,对肠炎宁颗粒中的没食子酸活性成分进行含量测定。同时,建立数学模型,量化仪器误差、操作误差、样品制备误差等多个不确定度来源。结果优化后的色谱技术显著提高了肠炎宁颗粒中活性成分的检测灵敏度和准确性。没食子酸的含量为27.5 mg,色谱峰峰形对称,分离度和理论板数均达到理想水平。不确定度分析表明,总不确定度较小(U_(total)=5.40%),表明优化后的色谱技术具有较高的可靠性。结论本研究成功优化了肠炎宁颗粒含量测定的HPLC方法,通过对不确定度的全面评估,证明了该方法的准确性和可靠性。这为肠炎宁颗粒的质量控制提供了一种更为精确和可靠的分析手段,同时也为中药制剂现代化分析提供了新的方法论。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 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(U_(total)=5.40%),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.

关 键 词：肠炎宁颗粒 高效液相色谱 含量测定 不确定度分析 中药制剂质量控制 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]