【摘要】：目的:建立超高效液相色譜-四極桿-靜電場(chǎng)軌道阱高分辨質(zhì)譜法定量檢測(cè)拉坦前列素滴眼液中15S-拉坦前列素。方法:采用色譜柱Thermo Accucore-C_(18)(2.1mm×150 mm,2.6μm);流動(dòng)相為甲醇-乙腈-水(用冰乙酸調(diào)節(jié)p H3.0)(48∶12∶40);流速為0.3 m L·min~(-1);柱溫為35℃;進(jìn)樣量為10μL。采用HESI離子源,正離子掃描模式,掃描范圍為m/z 300~600。采用Full MS模式提取離子方式檢測(cè),拉坦前列素與15S-拉坦前列素的檢測(cè)離子均為[M+Na]~+m/z 455.277±0.003;電噴霧離子源霧化溫度為300℃;毛細(xì)管電壓為3.50 k V;離子傳輸管溫度為320℃。鞘氣為50 arb;輔助氣為10 arb;分辨率為(R)70 000。結(jié)果:15S-拉坦前列素質(zhì)量濃度在0.998 8~19.98 ng·m L~(-1)范圍內(nèi)線性關(guān)系良好,相關(guān)系數(shù)為r=0.999 8,平均回收率為96.8%(n=9);定量限為0.029 96 ng·m L~(-1);3批樣品中15S-拉坦前列素的含量分別為0.11%、0.24%、0.06%。結(jié)論:經(jīng)方法學(xué)驗(yàn)證,本方法可檢測(cè)拉坦前列素滴眼液中15S-拉坦前列素立體異構(gòu)體雜質(zhì)。
[Abstract]:Objective: to establish a high performance liquid chromatography-tetrapole-electrostatic field trap high resolution mass spectrometry (HRMS) method for the determination of 15 S- lattanprost in lattanprost eye drops. Methods: the mobile phase of Thermo Accucore-C18 (2.1mm 脳 150mm-1) was methanol-acetonitrile-water (adjusted with glacial acetic acid) (48:12:40), the flow rate was 0.3 mL 路min ~ (-1), the column temperature was 35 鈩，

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