HPLC法测定氨己烯酸中有关物质的含量

Determination of related substance in vigabatrin by HPLC

目的建立高效液相色谱法测定氨己烯酸有关物质含量的方法。方法采用Spherisorb S5 C6色谱柱(250 mm×4.60 mm,5μm)串联Partisil-10 SCX色谱柱(250 mm×4.60 mm,10μm);乙腈为流动相A,质量浓度为1.7 g·L-1的二水·磷酸二氢钠溶液(含体积分数0.06%磷酸)为流动相B(体积比7∶93),流速为1.0 m L·min-1;检测波长为210 nm;柱温为35℃;进样量为20μL。结果氨己烯酸与有关物质A、B、E及未知杂质均能良好分离;各有关物质在线性范围内线性关系良好,r≥0.999(n=8);回收率在90%~108%内(RSD≤6%),经对三批样品测定,有关物质的含量质量分数均低于限度(0.1%)。结论建立的方法可作为氨己烯酸有关物质的测定。

Objective To develop an HPLC method for determination of the related substances in the vigabatrin. Methods A Spherisorb S5 C6 column （ 250 mm × 4. 60 mm, 5 μm） tandem a Partisil-10 SCX column（250 mm × 4.60 mm, 10 m）were used with the mobile phase consist of acetonitrile-0. 17% dihydrate sodium dihydrogen phosphate solution （0. 06 % phosphoric acid） （ V： V = 7：93 ）. The flow rate was 1.0 mL,min-1 and the injection volume was 20 μL. The detection wavelength was set as 210 nm and the column temperature was 35 ℃. Results All the related substances gained a completely chromatographic separation. Good linear relationships of three related substances were obtained （ r ≥0. 999 ） and recoveries were in the range of 90%- 108%. The content of the related substances in 3 batches of samples were below 0. 1%. Conclusions The established method is simple, accurate and highly sensitive and specific, and it can be applied to determine the contents of vigabatrin and related compounds.