本文選題：伊曲康唑 + 有關(guān)物質(zhì)　； 參考：《中國抗生素雜志》2015年02期

【摘要】：目的建立高效液相色譜梯度洗脫法測定伊曲康唑的有關(guān)物質(zhì)。方法采用反相高效液相色譜法,色譜柱為Alltech Hypersil BDS(100mm×4.6mm,3μm);以0.02mol/L硫酸氫四丁基銨溶液為流動相A,乙腈為流動相B,進(jìn)行線性梯度洗脫;流速為1.5m L/min;檢測波長為225nm。結(jié)果伊曲康唑及各已知雜質(zhì)、中間體均能達(dá)到基線分離,樣品中各雜質(zhì)及主峰的分離度和檢測靈敏度均滿足有關(guān)物質(zhì)的測定要求。結(jié)論 方法靈敏、準(zhǔn)確,專屬性強(qiáng),可用于測定伊曲康唑的有關(guān)物質(zhì)。
[Abstract]:Objective to establish a gradient elution method for the determination of itraconazole by HPLC. Methods Reversed-phase high performance liquid chromatography (RP-HPLC) was used, the column was Alltech Hypersil BDS(100mm 脳 4.6 mm ~ (3) 渭 m ~ (-1), the mobile phase was 0.02mol/L H _ 2SO _ 4 _ 4 Ding Ji ammonium solution, and acetonitrile was used as mobile phase B, the flow rate was 1.5 mL / min and the detection wavelength was 225 nm. Results itraconazole and all known impurities and intermediates could achieve baseline separation. The separation degree and detection sensitivity of each impurity and main peak in the sample could meet the requirements of the determination of related substances. Conclusion the method is sensitive, accurate and specific. It can be used to determine the related substances of itraconazole.
【作者單位】： 天津市藥品檢驗所;
【基金】：《中華人民共和國藥典》2010年版質(zhì)量標(biāo)準(zhǔn)起草項目
【分類號】：R927.1;O657.72

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本文編號：1964294