摘要
目的建立测定注射用别嘌醇钠有关物质的高效液相梯度洗脱法。方法采用ODSC18色谱柱（250mm×6mm，5μm），以1．25g·L^-1磷酸二氢钾-甲醇（体积比为90：10～70：30）为流动相进行梯度洗脱，柱温为30℃，流速为1．0mL·min^-1，检测波长为230nm。结果在上述色谱条件下。5种杂质（1—5）能与别嘌醇得到有效分离，分离度大于1．5；检测限为4．5ng，精密度良好（RSD为0．71％）。结论高效液相梯度洗脱法可用于测定注射用别嘌醇钠中的有关物质。
Objective To establish a reversed phase high performance liquid chromatography gradient elution method for determination of the related substances in allopurinol sodium for injection. Methods The related substances were separated on ODS C18 column（5 μm, 6.0 mm × 250 mm） at 30 ℃ with a flow rate of 1.0 mL· min^-1, 1.25 g· L^- 1 of potassium dihydrogen phosphate -methanol was used as mobile phase, a gradient elution was performed （ V ： V = 90 ： 10 - 70 ： 30）. The detection wavelength was set at 212 nm. Resuits The lowest limit for determination was 4.5 ng and the precision was good with RSD of 0.71%. Conclusions The reversed phase high performance liquid chromatography gradient elution method is simple and accurate for the determination of the related substances in allopurinol sodium injection.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2007年第4期223-225,258,共4页
Journal of Shenyang Pharmaceutical University
关键词
别嘌醇钠
有关物质
高效液相梯度洗脱法
allopurinol sodium
related compounds
reversed phase high performance liquid chromatography gradient elution method
