【摘要】：目的系統(tǒng)比較電噴霧檢測(cè)器、蒸發(fā)光散射檢測(cè)器、脈沖安培生化學(xué)檢測(cè)器3種方法測(cè)定依替米星注射液的有關(guān)物質(zhì),建立有關(guān)物質(zhì)檢測(cè)方法。方法建立的HPLC-CAD方法以0.2 mol·L~(-1)三氟乙酸-甲醇(95∶5)為流動(dòng)相,流速為1.0 mL·min~(-1),柱溫為30℃,霧化溫度30℃,氣壓0.24 MPa,HPLC-ELSD和HPLC-PAD方法采用《中國(guó)藥典》2015年版條件。結(jié)果 HPLC-CAD方法與HPLC-ELSD方法相比,分離度和靈敏度更高;與HPLC-PAD法比較,雜質(zhì)測(cè)定結(jié)果更準(zhǔn)確。結(jié)論建立的HPLC-CAD法分離能力強(qiáng),檢測(cè)出的雜質(zhì)更多,可作為硫酸依替米星注射液有關(guān)物質(zhì)測(cè)定的常規(guī)方法。
[Abstract]:Objective to systematically compare the determination of related substances in etimicin injection by electrospray detector, evaporative light scattering detector and pulse ampere chemical detector, and to establish a method for the determination of related substances. Methods the HPLC-CAD method was established with 0.2 mol 路L ~ (- 1) trifluoroacetic acid-methanol (95:5) as the mobile phase, the flow rate was 1.0 mL 路min ~ (- 1), the column temperature was 30 鈩，

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