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 Platform 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
Available Online: 2024-11-23

Abstract

Abstract

Objective Uncertainty assessment was conducted to increase the reliability of the content determination results for the high-risk preparation of Ambroxol hydrochloride injection. Methods The uncertainty assessment of the content determination results using the HPLC external standard method was carried out by synthesizing the bias uncertainty component and the intermediate precision uncertainty component through the application of the TOP-DOWN method. Results The expanded uncertainty assessed by the TOP-DOWN method at a confidence level of 95% was 1.84%. Conclusion The assessment results indicated that the TOP-DOWN method was effectively used to evaluate the uncertainty of the content determination results for pharmaceuticals, and was considered a reliable non-GUM assessment method.
- TOP-DOWN method,
- Ambroxo hydrochloride injection,
- Content determination,
- Uncertainty assessment

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References(15)

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