Uncertainty Evaluation of the Determination of the Content of Ambroxol Hydrochloride Injection by Using TOP-DOWN Method

Yongfei LI; Wenfen GAO; Jihua LIU; Yunhua ZHANG; Anbin LIU; Yuena YANG

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Yongfei LI, Wenfen GAO, Jihua LIU, Yunhua ZHANG, Anbin LIU, Yuena YANG. Uncertainty Evaluation of the Determination of the Content of Ambroxol Hydrochloride Injection by Using TOP-DOWN Method[J]. Journal of Kunming Medical University.

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Uncertainty Evaluation of the Determination of the Content of Ambroxol Hydrochloride Injection by Using TOP-DOWN Method

1.
Yunnan Institute for Food and Drug control，Industrial Technology Basic Public Service latform of the Ministry of Industry and Information Technology，Kunming Yunnan 650106
2.
Kunming Medical University，Kunming Yunnan 650500
3.
Zhaotong Vocational College of Health，Zhaotong Yunnan 657000，China

Received Date: 2024-05-07

Abstract

Abstract

Objective As a high-risk pharmaceutical preparation, the Ambroxo Hydrochloride Injection has not been reported to have the uncertainty evaluation of its content determination. It is necessary to conduct an uncertainty evaluation to scientifically explain the test results, increase the reliability of test results, and ensure the safety and effectiveness of the drug. Methods Using the TOP-DOWN method to evaluate the uncertainty of the content determination results obtained by HPLC external standard method, by combining the bias uncertainty component and the precision uncertainty component. Results When the confidence level is 95%, the expanded uncertainty evaluated by the TOP-DOWN method is 1.84%. Conclusion The TOP-DOWN method can effectively evaluate the uncertainty of the content determination results of pharmaceuticals. The assessment results indicate that the content determination data is reliable, and this provides a valuable reference method for exploring the evaluation of measurement uncertainty of pharmaceuticals using non-GUM methods.
- TOP-DOWN method,
- Ambroxo hydrochloride injection,
- Content determination,
- Uncertainty assessment

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References(15)

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