中国药房2016，Vol.27Issue(24)：3428-3430,3.DOI:10.6039/j.issn.1001-0408.2016.24.36
HPLC法测定比沙可啶肠溶片含量的测量不确定度评定
Evaluation of Measurement Uncertainty for the Content of Bisacodyl Enteric-coated Tablet by HPLC
孙婷 1姜建国 1张菁 1耿韫1
作者信息
- 1. 河北省药品检验研究院，石家庄 050011
- 折叠
摘要
Abstract
OBJECTIVE:To a evaluation method for the measurement uncertainty for the content of Bisacodyl enteric-coated tablet. 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 in processes of solution preparation and instrument measurement. RESULTS:HPLC external standard method showed the content was 97.8%,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 en-teric-coated tablet. Regularly calibrated verification for HPLC equipment and strict control of the weighing process will help to im-prove the accuracy measured by HPLC.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Key words
HPLC/Bisacodyl enteric-coated tablet/Content determination/Evaluation of measurement uncertainty分类
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孙婷,姜建国,张菁,耿韫..HPLC法测定比沙可啶肠溶片含量的测量不确定度评定[J].中国药房,2016,27(24):3428-3430,3.
