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 enteric-coated tablet. Regularly calibrated verification for HPLC equipment and strict control of the weighing process will help to improve 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
Keywords
HPLCBisacodyl enteric-coated tabletContent determinationEvaluation of measurement uncertainty