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目的评定HPLC法测定盐酸左氧氟沙星胶囊含量的不确定度。方法通过建立H-PLC法测定含量的数学模型,分析测量过程,确定不确定度来源。利用统计学方法,对各量化的分量进行评定,找出影响不确定度的因素。结果 HPLC法测定盐酸左氧氟沙星胶囊含量的扩展不确定度为1.8%,测量结果表示为(100.4±1.8)%,k=2。结论 HPLC法测定盐酸左氧氟沙星胶囊含量的测量不确定度评估,方法简单合理,保证了测量结果准确可靠。
Objective To assess the uncertainty of determination of levofloxacin hydrochloride by HPLC. Methods By establishing a mathematical model of content determination by H-PLC method, the measurement process was analyzed to determine the source of uncertainty. Using statistical methods, the quantitative components were assessed to identify the factors that affect the uncertainty. Results The extended uncertainty of 1.8% for the determination of levofloxacin hydrochloride by HPLC was (100.4 ± 1.8)% with k = 2. Conclusion The HPLC method for the determination of levofloxacin hydrochloride capsule measurement uncertainty, the method is simple and reasonable, to ensure accurate and reliable measurement results.