| 引用本文: | 石云峰,杨丽珍,林丽琴.HPLC测定草酸西酞普兰片有关物质[J].中国现代应用药学,2014,31(9):1117-1120. |
| SHI Yunfeng,YANG Lizhen,LIN Liqin.Determination of Citalopram Oxalate Tablets and Its Related Substances by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(9):1117-1120. |
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| 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。 |
| 关键词: 草酸西酞普兰 高效液相色谱法 梯度洗脱 |
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| Determination of Citalopram Oxalate Tablets and Its Related Substances by HPLC |
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SHI Yunfeng1, YANG Lizhen2, LIN Liqin3
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1.Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China;2.College of Chemical Engineering and Materials Science, Zhejiang University of Technology, Hangzhou 310014, China;3.Hangzhou Institute for Food and Drug Control, Hangzhou 310017, China
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| 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. |
| Key words: citalopram oxalate tablets HPLC gradient elution |
