HPLC法测定兰索拉唑肠溶片中13种有关物质

Determination of multiple related substances in lansoprazole enteric-coated tablets by HPLC

目的建立一种高效液相色谱法同时测定兰索拉唑肠溶片中13种有关物质。方法采用ECOSIL 120-5-C18 EPS柱(250 mm×4.6 mm,5μm),以乙腈作为流动相A相,以三乙胺-水(体积比为1∶60,用磷酸调pH值至6.2)作为流动相B相,梯度洗脱,柱温为30℃,流速为1.0 mL·min^-1,检测波长为285 nm,进样量为10μL。结果兰索拉唑与其杂质A、B、C、D、E、F、1、2、3、4、5、6、7均能良好分离,分离度大于2.0,各个杂质在线性范围内线性关系良好,回收率在97.1%~103.1%内(RSD%<2.0,n=6),方法耐用性良好。结论该方法能够用于兰索拉唑肠溶片中13个有关物质的测定。

Objective To develop an HPLC method for simultaneous determination of 13 impurities in lansoprazole enteric-coated tablets.Methods A ECOSIL 120-5-C18 EPS column(250 mm×4.6 mm,5μm)was used for chromatographic separation which was achieved by gradient program with acetonitrile as mobile phase A and triethylamine-water(V∶V=1∶60)as mobile phase B.The column temperature was maintained at 30℃,the flow rate was set as 1.0 mL·min-1,the detection wavelength was 285 nm and the injection volume was 10μL.Results Lansoprazole could be completely chromatographic separated with its impurities including A,B,C,D,E,F,1,2,3,4,5,6,7,and the resolutions were more than 2.0.Good linearity of all impurities in linearity range was obtained and percent recoveries were from 97.1%to 103.1%(RSD%<2.0,n=6).And the durability of this method was good.Conclusion This method can be applied to the determination of 13 impurities in lansoprazole enteric-coated tablets.