摘要
目的:建立测定缬沙坦氢氯噻嗪胶囊含量的不确定度分析方法。方法:采用高效液相色谱(HPLC)法测定缬沙坦和氢氯噻嗪含量及建立含量不确定度的数学模型,确定影响不确定度的因素如标准品质量和供试品质量等及其分量,并对各个不确定度因素进行评估。结果:分量中以标准品纯度和供试品内容物重量差异最大,是引起不确定度产生的主要原因;缬沙坦、氢氯噻嗪的扩展不确定度分别为1.72%、1.22%,含量测定结果可表示为(99.70±1.72)%、(99.74±1.22)%。结论:本方法可用于该制剂采用HPLC法测定含量时的不确定度分析。
OBJECTIVE ： To establish the method for analyzing measurement uncertainty of content determination of Valsartan/ hydrochlorothiazid capsules. METHODS： The mathematic model of uncertainty measurement was deduced and the content of valsartan/hydrochlorothiazid were determined by HPLC. The factors influencing the uncertainty were determined, such as the quality of standard substance and test sample, and the factors were evaluated. RESULTS： There was significant difference in purity of stan- dard substance and the content test sample, which were the main reasons for the uncertainty. The expanded uncertainty of valsartan and hydrochlorothiazid were 1.72% and 1.22% , respectively. The contents of valsartan and hydrochorothiazid were （99.70 ± 1.72） % and （99.74 ± 1.22）%. CONCLUSIONS： The method is applicable for the uncertainty analysis about the content determination of Valsartan/hydrochlorothiazid capsules by HPLC.
出处
《中国药房》
CAS
CSCD
2012年第5期445-447,共3页
China Pharmacy
