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更昔洛韦葡萄糖注射液中有关物质的检查
Determination of related substances in Ganciclovir and glucose injection
【摘要】 目的 建立更昔洛韦葡萄糖注射液中有关物质的检查方法。方法 采用HPLC法,确定了有关物质检查的最佳条件。用HypersilC18色谱柱(2 5 0mm×4 . 6mm ,10 μm) ,甲醇- 0 0 2mol·L-1KH2 PO3 (6∶94 )为流动相,流速1 0ml·min-1,在2 5 2nm处,采用杂质峰面积对照法对鸟嘌呤进行检查,采用不加校正因子的主成分自身对照法对其他有关物质进行检查。结果 鸟嘌呤及其他有关物质的最低检测限均为0 . 4ng(S/N =3) ,方法重复性的RSD分别为1 .30 %和1 .38% (n =6 )。结论 方法专属性强,灵敏度高,精密度好,可用于质量控制。
【Abstract】 OBJECTIVE To determine related substances of Ganciclovir and glucose injection. METHODS HPLC method was adopted.The best condition for determination of related substances in sample was eatablished and checked.RESULTS The related substances in sample were determined on the HPLC instrument fixed a Hypersil C 18column(250 mm×4.6 mm, 10 μm)with UV detection at 252 nm.The mobile phase consisted of methyle alcohol and 0.02 mol·L -1 KH 2PO 3(6∶94).The flow rate was 1.0 ml·min -1. CONCLUSION This method is simple, specific, sensitive. It is suitable for determining the related substances in Ganciclovir and glucose injection.
- 【文献出处】 华西药学杂志 ,West China Journal of Pharmaceutical Sciences , 编辑部邮箱 ,2005年02期
- 【分类号】R927
- 【被引频次】2
- 【下载频次】180