摘要
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 an HPLC method for the determination of related substances in lansoprazole for injection.Methods An Eclipse XDB-C18 column（250 mm×4.6 mm,5 μm）was adopted and the mobile phase was triethylamine aqueous solution with a volume fraction of 1.64%（adjusted to 6.2 with phosphoric acid）-acetonitrile（V∶ V=65∶ 35）at the flow rate of 1.0 mL·min-1.The column temperature was 35 ℃ and the wavelength was set at 285 nm.Results Lansoprazole and its related substances were completely separated.The average recoveries of related substances A,B,C,D,E and F were 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%）and 95.6%（RSD=2.2%）,respectively;the correction factors were 0.76,1.16,1.03,0.88,0.47 and 0.94,separately.Conclusion A specific and sensitive method is developed for the determination of related substances in lansoprazole for injection.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2013年第5期346-350,共5页
Journal of Shenyang Pharmaceutical University
