摘要
目的采用两种方法测定盐酸青藤碱纯度,并建立其不确定度评定方法。方法采用高效液相色谱法(HPLC)对盐酸青藤碱纯度进行测定,并依据标准物质技术规范及相关计量技术规范要求,对HPLC法测定过程的不确定度进行了系统分析,并采用酸碱非水滴定法对盐酸青藤碱纯度值进行验证。结果采用HPLC法测定盐酸青藤碱纯度的标准值及其不确定度为99.87%±0.41%(k=2,P=0.95)。酸碱非水滴定法测定纯度值为99.88%,在不确定度范围之内。结论采用HPLC与酸碱非水滴定法联合测定盐酸青藤碱纯度及不确定度评定结果准确可靠,避免了采用一种技术带来的分析方法缺陷,有利于提高盐酸青藤碱的质量评价与控制水平,同时对盐酸青藤碱纯度标准物质的研制提供了科学依据。
OBJECTIVE To measure the purity of Sinomenine Hydrochloride by two different principles meth-ods and establish a method for uncertainty evaluation .METHODS According to Technical Norm of Primary Refer-ence Material and Technical Norm of Measuremen , HPLC was selected to deterimiante the purity of Sinomenine Hydrochloride ,and the uncertainty evaluation was analyzed systematically .Sinomenine Hydrochloride purity value was verified by the non-aqueous acid-base titration.RESULTS By using HPLC method ,The standard value and un-certainty of Sinomenine Hydrochloride purity was 99.87%±0.41%（k=2,P=0.95）.The standard value of Sino-menine Hydrochloride purity was 99.88% by the non-aqueous acid-base titration within the uncertainty range.CONCLUSION The valuation and uncertainty evaluation in Purity determination of Sinomenine Hydrochlo-ride by using HPLC and non-aqueous acid-base titration is accurate and reliable , and avoids the defect by using a single analysis method ,it is helpful to improve the level of quality evaluation and control of Sinomenine Hydrochlo-ride,and provide a scientific basis for the development of Sinomenine Hydrochloride purity reference materials .
出处
《海峡药学》
2014年第12期46-49,共4页
Strait Pharmaceutical Journal
关键词
盐酸青藤碱
纯度
不确定度
HPLC
酸碱非水滴定法
Sinomenine Hydrochloride
Purity
Uncertainty
HPLC
Non-aqueous acid-base titration
