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目的建立测定注射用兰索拉唑有关物质的HPLC方法。方法色谱柱为Eclipse XDB-C18柱(250 mm×4.6 mm,5μm),流动相为体积分数1.64%三乙胺水溶液(磷酸调pH值至6.2)-乙腈(体积比65∶35),流速为1.0 mL.min-1,柱温为35℃,检测波长为285 nm。结果兰索拉唑与各有关物质均能得到良好分离,有关物质A、B、C、D、E和F的平均回收率分别为96.9%(RSD=1.6%)、98.2%(RSD=1.7%)、102.0%(RSD=2.3%)、97.9%(RSD=1.7%)、97.2%(RSD=1.9%)和95.6%(RSD=2.2%),校正因子分别为0.76、1.16、1.03、0.88、0.47和0.94。结论该方法专属性强、灵敏度高,可用于注射用兰索拉唑有关物质的测定。
Objective To establish a HPLC method for the determination of lansoprazole related substances for injection. Methods The column was an Eclipse XDB-C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of 1.64% triethylamine in water (adjusted to pH 6.2 with phosphoric acid) -acetonitrile (65:35 by volume) at a flow rate of 1.0 mL.min-1, the column temperature was 35 ℃, the detection wavelength was 285 nm. As a result, lansoprazole was well separated from all related substances, and the average recoveries of related substances A, B, C, D, E and F were 96.9% (RSD = 1.6%), 98.2% (RSD = 1.7% (RSD = 2.3%), 97.9% (RSD = 1.7%), 97.2% (RSD = 1.9%) and 95.6% (RSD = 2.2%). The calibration factors were 0.76,1.16,1.03,0.88, 0.47 and 0.94. Conclusion The method is specific and sensitive and can be used for the determination of related substances of lansoprazole for injection.