高效液相色谱法测定磷酸咯萘啶及其注射液中有关物质的含量  

Determination of related substances in malaridine phosphate and malaridine phosphate injection by HPLC

作　　者：寻延滨 敖红光[2] 孙煌 杨杨 贾飞 白政忠 

机构地区：[1]黑龙江省食品药品检验检测所,哈尔滨150001 [2]哈尔滨理工大学测控技术与通信工程学院,哈尔滨150080 [3]浙江省食品药品检验研究院,杭州310004

出　　处：《中南药学》2013年第11期840-842,共3页Central South Pharmacy

基　　金：世界卫生组织的全球基金项目(编号:GF2012-49;编号:GF2012-50)

摘　　要：目的建立HPLC梯度洗脱法测定磷酸咯萘啶及其注射液的有关物质。方法采用Sepax sapphire H C18（25cm×4.6 mm,5μm）色谱柱,以磷酸盐缓冲液（称取磷酸二氢钾6.81 g,加水1 000 mL溶解,加1 mL三乙胺,用磷酸调节pH至2.8）-甲醇（85：15）为流动相A,甲醇为流动相B,梯度洗脱,检测波长278 nm。结果在选定的色谱条件下磷酸咯萘啶中的杂质完全洗脱,主峰与各杂质峰均能良好的分离,磷酸咯萘啶浓度在0.5~8μg mL-1与峰面积线性关系良好,r=0.999 6。结论本方法专属性强,灵敏度高,可准确测定磷酸咯萘啶及其注射液中的有关物质,为质量标准的修订及完善提供了依据。Objective To establish an HPLC method for the determination of the related substances of malaridine phosphate and malaridine phosphate injection. Methods Chromatographic analysis was performed on a Sepax sapphire H C 18（25 cm×4.6 mm, 5 μm） column. Mobile phase A consisted of methanol-phosphate buffer（dissolving KH 2 PO 4 6.81 g and 1 mL triethylamine in 1 000 mL water, adjusting pH to 2.8 with phosphate）（15 ：85）, while mobile phase B was methanol. The detection wavelength was 278 nm. Results The main peak of malaridine phosphate and its impurities were well separated under selected liquid chromatographic system. Malaridine phosphate had a good linearity（r = 0.999 6, n = 5） with the peak area at 0.5- 8 μg mL- 1. Conclusion This method is specific, sensitive, and can be applied to detect the related substances in malaridine phosphate and malaridine phosphate injection accurately, thus improving the quality standard.

关 键 词：磷酸咯萘啶 梯度洗脱 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]