关键词: 鲑降钙素鼻喷雾剂, 不确定度, 鲑降钙素, 含量测定

Abstract:

Objective： To establish an evaluation method for the uncertainty in determination of salmon calcitonin content in salmon calcitonin nasal spray.Methods： The content determination of salmon calcitonin was carried out according to the national drug standard YBH05252003-2014Z. At the same time， according to the relevant provisions of "Evaluation and Representation of Measurement Uncertainty" JJF 1059.1-2012， an mathematical model for uncertainty in determining salmon calcitonin content was established， and the sources of uncertainty were analyzed and evaluated.Results： The main sources of uncertainty of salmon calcitonin content were reference substance weighing （M_R）， reference substance solution preparation （C_V）， test substance solution preparation （V_S）， test substance measurement repeatability （S_S） and the repeatability of the integrated peak area of the reference substance （R）. The combined uncertainty of the determination of salmon calcitonin content in salmon calcitonin nasal spray by external standard HPLC was 0.177 6 μg·mL^-1， and the expanded uncertainty was 0.355 2 （k=2， confidence probability was 95%）.Conclusion： The contribution to the uncertainty in determination of salmon calcitonin contern in salmon calcitonin nasal spray mainly comes from the preparation of the test solution and the repeatability of the test of standard substance， while the weighing and preparation of the reference substance have a small contribution to the uncertainty. To reduce the uncertainty in the determination of salmon calcitonin， special attention should be paid to the preparation of the test sample during the experiment， and the operation of the experimenter should be standardized. The experimental instruments need to be calibrated regularly to reduce the generation of uncertainty. This study quantified the uncertainty of this measurement and analysis method. The established method is suitable for the uncertainty evaluation of the determination of salmon calcitonin content in salmon calcitonin nasal spray by external standard HPLC.

Key words:  , Salmon calcitonin nasal spray； , Uncertainty； , Salmon calcitonin； , Content determination