本文選題：米拉貝隆 + 降解雜質(zhì)��； 參考：《中國(guó)醫(yī)藥工業(yè)雜志》2017年10期

【摘要】：建立了超高效液相色譜(UPLC)法測(cè)定米拉貝隆原料藥中的3種降解雜質(zhì)。采用Acquity UPLC BEH C_(18)色譜柱,以5 mmol/L庚烷磺酸鈉溶液∶20 mmol/L磷酸二氫鉀溶液(用磷酸調(diào)至pH 3.0)為流動(dòng)相A,以乙腈為流動(dòng)相B,線(xiàn)性梯度洗脫,檢測(cè)波長(zhǎng)220 nm。采用加校正因子的主成分自身對(duì)照法,以米拉貝隆為參照物,分別測(cè)定其與降解雜質(zhì)之間的相對(duì)保留時(shí)間(RRT)及相對(duì)校正因子(RCF),以RCF對(duì)米拉貝隆中的3種降解雜質(zhì)進(jìn)行定量分析,并與標(biāo)準(zhǔn)曲線(xiàn)法測(cè)定結(jié)果比較,以驗(yàn)證方法的準(zhǔn)確性。3種降解雜質(zhì)的RRT分別為0.53、0.78和1.22;RCF分別為1.38、1.63和1.25;RCF法與標(biāo)準(zhǔn)曲線(xiàn)法測(cè)定結(jié)果無(wú)顯著性差異。本方法能夠準(zhǔn)確測(cè)定米拉貝隆原料藥中的3種降解雜質(zhì)。
[Abstract]:A high performance liquid chromatography (UPLC) method was developed for the determination of three degradable impurities in Milabelon. The mobile phase A was 5 mmol/L sodium heptane sulfonate solution: 20 mmol/L potassium dihydrogen phosphate (adjusted to pH 3.0 with phosphoric acid) and the mobile phase B was acetonitrile. The detection wavelength was 220nm. The relative retention time (RRT) and the relative correction factor (RCF) between Mira Belon and the degradation impurities were determined by using the principal component self-control method with correction factor. The three kinds of degradation impurities in Mirabelon were quantitatively analyzed by RCF. Compared with the standard curve method, the accuracy of the method was not significantly different from that of the standard curve method. The RRT of the three kinds of impurities were 0.53 ~ 0.78 and 1.22 ~ 0.78, 1.38 ~ (1.63) and 1.25 ~ (%), respectively. This method can accurately determine three kinds of degradation impurities in Milabelon.
【作者單位】： 莒縣人民醫(yī)院;臨沂萊博醫(yī)藥技術(shù)有限公司;
【分類(lèi)號(hào)】：O657.72;TQ460.72
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本文編號(hào)：1938239