摘要
目的:建立测定比沙可啶肠溶片含量的测量不确定度的评定方法。方法:采用高效液相色谱(HPLC)外标法测定比沙可啶肠溶片的含量,并建立评定其不确定度的数学模型,对来自于溶液配制过程和仪器测定过程的各种不确定度影响因素进行系统分析并予以评估。结果:HPLC外标法测定比沙可啶肠溶片的含量为97.8%,置信概率为95%时,其扩展测量不确定度为2.8%,测量结果表示为(97.8±2.8)%,k=2。结论:建立的方法适用于HPLC外标法测定比沙可啶肠溶片含量的测量不确定度评定。HPLC仪器的定期校准检定和称量过程的严格控制有利于提高HPLC法测定的准确度。
OBJECTIVE:To a evaluation method for the measurement uncertainty for the content of Bisacodyl enteric-coatedtablet. METHODS:HPLC external standard method was conducted for content determination of Bisacodyl enteric-coated tablet,and mathematical model for uncertainty evaluation was established to systematically analyze and evaluate the influential factors inprocesses of solution preparation and instrument measurement. RESULTS:HPLC external standard method showed the content was97.8% ,confidence probability was 95% ,expanded uncertainty was 2.8% ,and determination result was(97.8 ± 2.8)% ,k=2.CONCLUSIONS:The established method is suitable for the evaluation of measurement uncertainty for the content of Bisacodyl enteric-coated tablet. Regularly calibrated verification for HPLC equipment and strict control of the weighing process will help to improvethe accuracy measured by HPLC.
作者
孙婷
姜建国
张菁
耿韫
SUN Ting;JIANG Jianguo;ZHANG Jing;GENG Yun(Hebei Institute for Drug Control,Shijiazhuang 050011,China)
出处
《中国药房》
CAS
北大核心
2016年第24期3428-3430,共3页
China Pharmacy
关键词
高效液相色谱法
比沙可啶肠溶片
含量测定
测量不确定度评定
HPLC
Bisacodyl enteric-coated tablet
Content determination
Evaluation of measurement uncertainty
