HPLC法测定草酸艾司西酞普兰片的含量

目的:建立高效液相色谱法测定草酸艾司西酞普兰片的含量。方法:采用Amethyst C₁₈-P色谱柱(150 mm×4.6 mm,5 μm),以pH 4.20醋酸钾缓冲液(取醋酸钾14 g,加冰醋酸20.5 mL,加水稀释至1000 mL)-乙腈(72:28)为流动相,流速1.0 mL·min^-1,检测波长236 nm,测定草酸艾司西酞普兰的含量。结果:草酸艾司西酞普兰质量浓度在20~300 μg·mL^-1范围内线性关系良好;平均回收率(n=3)为99.1%~99.4%,RSD为0.25%~0.61%,以每片中艾司西酞普兰计,3批样品的含量分别为99.7%、99.5%、99.5%。结论:本法经方法学验证,可用于本制剂的含量测定及质量控制。

Objective:To establish the method for the content determination of escitalopram oxalate tablets.Method: The Amethyst C₁₈-P column(150 mm×4.6 mm,5 μm) was used with pH 4.20 potassium acetate buffer(taking 14 g of potassium acetate,added with 20.5 mL glacial acetic acid,diluted with water to 1000 mL)-acetonitrile(72:28) as the mobile phase,with a flow rate of 1.0 mL·min^-1 and the detection wavelength at 236 nm to detect the content of escitalopram oxalate.Results:The calibration curve was linear in the range of 20-300 μg·mL^-1,the average recovery(n=3) was 99.1%-99.4% with RSD of 0.25%-0.61%.In escitalopram count per tablet,the content of three batches of samples was 99.7%,99.5%,and 99.5%,respetively.Conclusion: It is proved by methodology validation that the method can be used for the determination and quality control of the preparation.

[1] 张爱娥.艾司西酞普兰治疗老年抑郁症临床疗效观察[J].中国实用医药,2011,6(20):1623 ZHANG AE.Clinical efficacy of geriatric depression escitalopram treatment[J].China Pract Med,2011,6(20):1623
[2] CHEN F,LARSEN MB,SÁNCHEZ C,et al.The S-enantiomer of R,S-citalopram,increases inhibitor binding to the human serotonin transporter by an allosteric mechanism.Comparison with other serotonin transporter inhibitors[J].Eur Neuropsychopharmacol, 2005,15(2):193
[3] 潘红娟,朱雪炎.氢溴酸西酞普兰的手性拆分及草酸依地普仑ee值检查[J].中国医药工业,2004,35(8):484 PAN HJ,ZHU XY.Chiral separation of citalopram hydrobromide enantiomers and ee of escitalopram oxalate[J].Chin J Pharm, 2004,35(8):484
[4] 中国药典2010年版.二部[S].2010:附录194 ChP 2010.Vol Ⅱ[S].2010:Appendix 194
[5] 代亚,付涛,俞丽君,等.高效液相色谱法测定草酸艾司西酞普兰片的含量[J].中国药业,2011,20(16):33 DAI Y,FU T,YU LJ,et al.Determination of escitalopram oxalate tablets by HPLC[J].China Pharm,2011,20(16):33
[6] 余以兵,杨永林,金俊华,等.高效液相色谱法测定草酸艾司西酞普兰中的有关物质[J].广州化工,2011,39(24):102 YU YB,YANG YL,JIN JH,et al.Determination of related substances of escitalopram oxalate with high performance liquid chromatography[J].Guangzhou Chem Ind Technol,2011,39(24):102
[7] SUNIL RD,MAHADEO VM.Column liquid chromatography ultraviolet and column liquid chromatography/mass spectrometry evaluation of stress degradation behavior of escitalopram oxalate[J].Drug Formul Clin Methods,2009,1(92):138
[8] 车明徽,梁林,李永吉.HPLC法测定草酸艾司西酞普兰片的有关物质[J].黑龙江医药,2015,1(28):66 CHE MH,LIANG L,LI YJ.HPLC method for escitalopram oxalate citalopram piece of related substance[J].Heilongjiang Med J, 2015,1(28):66