HPLC法测定草酸艾司西酞普兰片的含量

发布时间：2019-04-27 00:38

【摘要】：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,5μm),以p H 4.20醋酸钾缓冲液(取醋酸钾14 g,加冰醋酸20.5 m L,加水稀释至1 000 m L)-乙腈(72∶28)为流动相,流速1.0 m L·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20~300μg·m L~(-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。
[Abstract]:Objective: to establish a HPLC method for the determination of isophthalopram oxalate tablets. Methods: a Amethyst C18 P column (150 mm 脳 4.6 mm, 5 渭 m) was used with pH 4.20 potassium acetate buffer solution (14 g potassium acetate, 20.5 mL glacial acetic acid) and diluted to 1 000 m L)-acetonitrile (72:28) as mobile phase. The flow rate was 1.0ml 路min ~ (- 1), the detection wavelength was 236nm, and the content of isophthalopram oxalate was determined. Results: the linear range of isophthalopram oxalate was 20 ~ 300 渭 g 路mL ~ (- 1). The average recovery (n = 3) was 99.1% ~ 99.4% with RSD of 0.25% ~ 0.61%. The contents of the three batches were 99.7%, 99.5% and 99.5%, respectively, based on escitalopram in each tablet. Conclusion: this method can be used for the content determination and quality control of this preparation.
【作者单位】：湖北科技学院药学院;
【分类号】：R927.2;O657.72

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