HPLC法测定清开灵注射液中黄芩苷含量的不确定度分析

目的:分析HPLC法测定清开灵注射液中黄芩苷含量的不确定度。方法:通过建立HPLC法测定含量的数学模型,找出影响不确定度的因素,并对各个不确定度因素进行评估、计算,由此计算合成不确定度,最终给出测量结果的扩展不确定度和置信水平。结果:合成不确定度为5.45×10-3;扩展不确定度为0.01;黄芩苷含量测定结果为(4.02±0.01)mg·mL-1。结论:本方法可用于HPLC法测定药物含量的不确定度的分析。

Uncertainty Analysis on HPLC Method for the Determination of Baicalin in Qingkailing Injection

OBJECTIVE: To analyze the uncertainty involved in HPLC method for the determination Baicalin in Qingkai-ling injection. METHODS: Through establishing HPLC determination mathematical model, the factors affecting the uncertainty were deduced. Each component of uncertainty was evaluated and calculated, from which the combined uncertainty and finally the extended uncertainty and confidence level were obtained. RESULTS: The combined uncertainty was 5.45×10-3, extended uncertainty was 0.01, and the determined content of Baicalin was (4.02±0.01) mg·mL-1. CONCLUSION: The established analytical method is applicable to the uncertainty analysis of HPLC method in the determination of drugs.