HPLC法测定药物含量不确定度评定  

Assessment of the Uncertainty of Drug Content Determination with HPLC Method

作　　者：郑丽[1] 郭伟英[1] 

机构地区：[1]辽宁医学院,辽宁锦州121000

出　　处：《辽宁医学院学报》2012年第3期265-267,共3页Journal of Liaoning Medical University (LNMU) Bimonthly

摘　　要：目的建立高效液相色谱法测定安博诺片含量的不确定度分析方法。方法建立高效液相色谱含量测定的不确定度分析数学模型,找出影响不确定度的因素并对不确定度分量进行评定。结果安博诺中厄贝沙坦和氢氯噻嗪含量的扩展部确定度分别1.42%和1.38%,含量测定结果分别为:98.5%±1.42%(K=2)和101.3%±1.38%(K=2)。结论建立的不确定度分析与计算方法适用于HPLC法含量测定的不确定度评定。Objective To establish a method for evaluating uncertainties in the assay with HPLC. Methods The calculation formulas for the uncertainties of the assay with HPLC were deduced. The factors affecting uncertainty were iden- tified and then the uncertainty was assessed. Results The expanded certainty of Irbesartan and Hydrochlorothiazide were 1. 42% and 1. 38% respectively. The assay results of Irbesartan and Hydrochlorothiazide were 98. 5%± 1.42% （ K = 2） and 101.3%± 1.38% （ K = 2） respectively. Conclusion The analysis and calculation method for uncertainty is suitable for the uncertainties of the assay with HPLC.

关 键 词：HPLC 含量测定 不确定度 

分 类 号：R917[医药卫生—药物分析学]