HPLC测定草酸西酞普兰片有关物质  

Determination of Citalopram Oxalate Tablets and Its Related Substances by HPLC

作　　者：石云峰 杨丽珍[2] 林丽琴[3] 

机构地区：[1]浙江省食品药品检验研究院,杭州310004 [2]浙江工业大学化材学院,杭州310014 [3]杭州市食品药品检验研究院,杭州310017

出　　处：《中国现代应用药学》2014年第9期1117-1120,共4页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立HPLC测定草酸西酞普兰片有关物质的方法。方法采用Kromasil 100-5C18柱（250 mm×4.6 mm,5μm）,梯度洗脱,流动相A为乙腈-磷酸盐缓冲液（pH 3.0）（10∶90）,流动相B为乙腈-磷酸盐缓冲液（pH 3.0）（65∶35）;流速为1.0 mL·min-1;检测波长为237 nm。结果草酸西酞普兰与其他杂质分离度较好,草酸西酞普兰的线性范围为0.205~1.536μg·mL-1（r=0.999 5）,草酸西酞普兰检测限浓度为0.06μg·mL-1。结论方法简便、准确,专属性强,可作为产品有关物质检测方法。OBJECTIVE To establish a method for related substances determination of citalopram oxalate tablets by HPLC. METHODS The Kromasil 100-5C18 column（250 mm×4.6 mm,5μm） was used. The mobile phase consisted of two solvents A and B with gradient elution. The A solvent was acetonitrile-buffer（pH 3.0） （10 ： 90）; the B solvent was acetonitrile-buffer（pH 3.0） （65 ; 35）. The flow rate was 1.0 mL.min-1. The detection wavelength was 237 nm. RESULTS The calibration curves of citalopram oxalate was linear in the range of 0.205-1.536 μg.mL-1（r=0.999 5）, The detection limit of citalopram oxalate was 0.06μg mL-1. CONCLUSION The method is rapid, accurate and reliable for related substances determination of citalopram oxalate tablets.

关 键 词：草酸西酞普兰 高效液相色谱法 梯度洗脱 

分 类 号：R917.101[医药卫生—药物分析学]