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

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，5 μm)，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~ 1.536 μg·mL^-1(r=0.999 5)，草酸西酞普兰检测限浓度为0.06 μg·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。

Abstract: 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, 5 μm) 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 0.06 μg·mL^-1. CONCLUSION The method is rapid, accurate and reliable for related substances determination of citalopram oxalate tablets.