【摘要】：目的:建立測定比沙可啶原料藥純度及不確定度評定的方法。方法:采用差示掃描量熱(DSC)法對比沙可啶原料藥純度進行測定,確定最優(yōu)檢測條件;依據(jù)相關標準,對儀器校準銦標定焓變、測量重復性、稱量過程、儀器溫度偏差、系統(tǒng)軟件偏差5個不確定度分量進行系統(tǒng)分析。采用高效液相色譜(HPLC)法對結果進行驗證。結果:置信概率P為0.95時,采用DSC法測定比沙可啶原料藥純度結果的標準值及其不確定度為(99.88±0.06)%。其中稱量過程、儀器溫度偏差和系統(tǒng)軟件偏差對總不確定度影響較大。DSC法與HPLC法測定結果一致。結論:所建立的DSC法可以快速、準確地測定比沙可啶原料藥純度,為其純度測定提供了一種新的分析方法。DSC儀器的定期校準檢定和稱量過程的嚴格控制有利于提高DSC法測定的準確度。
[Abstract]:Objective: to establish a method for the determination of the purity and uncertainty of Bizacodine. Methods: using differential scanning calorimetry (DSC) to compare the purity of sackadine raw material to determine the optimal detection conditions, calibrating the indium enthalpy change, measuring repeatability, weighing process and instrument temperature deviation according to the relevant standards. The system software deviation is analyzed by 5 uncertainty components. The results were verified by high performance liquid chromatography (HPLC). Results: when the confidence probability P was 0. 95, the standard value and uncertainty of the determination of the purity of Bizacodine by DSC was (99.88 鹵0.06). Among them, the weighing process, the temperature deviation of the instrument and the deviation of the system software have great influence on the total uncertainty. The results obtained by DSC method and HPLC method are in agreement with each other. Conclusion: the established DSC method can be used to determine the purity of Bizacodine. This paper provides a new analytical method for the determination of its purity. The periodic calibration and calibration of the DSC instrument and the strict control of the weighing process are helpful to improve the accuracy of the determination by the DSC method.
【作者單位】： 河北省藥品檢驗研究院;天津農(nóng)學院基礎科學系;
【分類號】：R927.1

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