Evaluation of Measurement Uncertainty for the Content of Bisacodyl Enteric-coated Tablet by HPLC
10.6039/j.issn.1001-0408.2016.24.36
- VernacularTitle:HPLC法测定比沙可啶肠溶片含量的测量不确定度评定
- Author:
Ting SUN
;
Jianguo JIANG
;
Jing ZHANG
;
Yun GENG
- Publication Type:Journal Article
- Keywords:
HPLC;
Bisacodyl enteric-coated tablet;
Content determination;
Evaluation of measurement uncertainty
- From:
China Pharmacy
2016;27(24):3428-3430
- CountryChina
- Language:Chinese
-
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.
