Uncertainty of Determination of Western Medicine Composition Illegally Added into Chinese Patent Drug / 中国药房

ABSTRACT

OBJECTIVE: To analyze the uncertainty of determination of western medicine composition illegally added into Chinese patent drug and find out the effect factors of uncertainty in order to provide scientific basis for evaluating test report. METHODS: Antler tablets were tool as example. Qualitative analysis of additive composition was carried out using HPLC-MS method and the content of sildenafil citrate in each tablet was determined. Uncertainty of test was evaluated according to the regulation specified in Evaluation and Expression of Measurement of Uncertainty (JJF1059-1999). RESULTS: The uncertainty of the test is 0.10 mg in each tablet. CONCLUSION: The uncertainty of the experiment is mainly caused by non homogeneity of sample.