【摘要】：目的:建立測(cè)定比沙可啶原料藥純度及不確定度評(píng)定的方法。方法:采用差示掃描量熱(DSC)法對(duì)比沙可啶原料藥純度進(jìn)行測(cè)定,確定最優(yōu)檢測(cè)條件;依據(jù)相關(guān)標(biāo)準(zhǔn),對(duì)儀器校準(zhǔn)銦標(biāo)定焓變、測(cè)量重復(fù)性、稱量過(guò)程、儀器溫度偏差、系統(tǒng)軟件偏差5個(gè)不確定度分量進(jìn)行系統(tǒng)分析。采用高效液相色譜(HPLC)法對(duì)結(jié)果進(jìn)行驗(yàn)證。結(jié)果:置信概率P為0.95時(shí),采用DSC法測(cè)定比沙可啶原料藥純度結(jié)果的標(biāo)準(zhǔn)值及其不確定度為(99.88±0.06)%。其中稱量過(guò)程、儀器溫度偏差和系統(tǒng)軟件偏差對(duì)總不確定度影響較大。DSC法與HPLC法測(cè)定結(jié)果一致。結(jié)論:所建立的DSC法可以快速、準(zhǔn)確地測(cè)定比沙可啶原料藥純度,為其純度測(cè)定提供了一種新的分析方法。DSC儀器的定期校準(zhǔn)檢定和稱量過(guò)程的嚴(yán)格控制有利于提高DSC法測(cè)定的準(zhǔn)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(yàn)研究院;天津農(nóng)學(xué)院基礎(chǔ)科學(xué)系;
【分類號(hào)】：R927.1

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本文編號(hào)：2141907