Evaluation of Content Uncertainty of Vitamin D3 in Calcium Carbonate and Vitamin D3 Granules(Ⅱ)
Objective To establish the evaluation method of content uncertainty of vitamin D3 in Calcium Carbonate and Vitamin D3 Granules(Ⅱ).Methods The content of vitamin D3 was determined by the method in the WS1-XG-033-2021 National Drug Standard.According to the relevant provisions of JJF 1059.1-2012 Evaluation and Expression of Uncertainty in Measurement,a mathematical model for the content uncertainty of vitamin D3 was established,and the sources of uncertainty were analyzed and evaluated.Results The content uncertainty of vitamin D3 was mainly from purity of reference(PR),mass of reference(MR),preparation of reference solution(VR),determination of reference solution(AR),mass of samples(MS),preparation of sample solution(VS),average loading weight of samples(W),determination of sample solution(AS),high-performance liquid chromatography(HPLC)instrument(I),and method bias(B).The synthesis uncertainty of vitamin D3 content in Calcium Carbonate and Vitamin D3 Granules(Ⅱ)determined by the HPLC external standard method was 0.022 8,with an extended uncertainty of 3.22%(k = 2,confidence probability of 95%),and the relative standard uncertainty introduced by method bias was 1.83×10-2,which was a potential risk point.Conclusion The established method is suitable for evaluating the content uncertainty of vitamin D3 content in Calcium Carbonate and Vitamin D3 Granules(Ⅱ)by HPLC external standard method,but the recovery rate of the determination method is relatively low.It is recommended to conduct factor testing on this method to improve the testing method and increase the average recovery rate.
Calcium Carbonate and Vitamin D3 Granules(Ⅱ)uncertaintyvitamin D3content determination
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