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高效液相色谱法测定醋酸氟卡尼片的含量

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目的 建立醋酸氟卡尼片的含量测定方法.方法 通过高效液相色谱法,采用Alltima C18色谱柱(150mm×4.6mm,5 μm),流动相为乙腈-0.02 mol·L-1磷酸二氢铵溶液(含0.2%三乙胺)(用磷酸调至pH 3.0)(35∶65),流速为1.0mL·min-1,检测波长为300 nm,柱温为30℃.结果 醋酸氟卡尼在196.0~588.0 μg·mL-1与峰面积呈良好的线性关系,相关系数为1.000;精密度、重复性和稳定性考察RSD均小于1.0%;低、中、高浓度的平均回收率在98.79%~99.20%,RSD均<1.0%.结论 该方法准确、简单、快速,能够用于醋酸氟卡尼片的含量测定.
Content determination of flecainide acetate tablets by high-performance liquid chromatography
Objective To determine the content of flecainide acetate tablets.Methods High performance liquid chromatography(HPLC)was used with an Alltima C18 column(150 mm×4.6 mm,5 μm).The mobile phase was acetonitrile-0.02 mol·L-1 ammonium dihydrogen phosphate solution(containing 0.2%triethylamine)(pH adjusted to 3.0 with phosphoric acid)(35∶65)with the flow rate of 1.0 mL·min-1.The detection wavelength was 300 nm and the column temperature was 30 ℃.Results There was a good linearity between flecainide acetate and peak area in a certain concentration range of 196.0~588.0 μg·mL-1,with the correlation coefficient(r)was 1.000.The relative standard deviations of precision,repeatability and stability were less than 1.0%.The average spiked recovery of low,middle,and high concentration was 98.79%~99.20%with relative standard deviation(RSD)all less than 1.0%(n=3).Conclusion The method is accurate,simple and rapid,and can be used for the content determination of flecainide acetate tablets.

flecainide acetateflecainide acetate tabletHPLCcontent determination

徐硕、邝咏梅、徐文峰、金鹏飞

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北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究院,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京 100730

醋酸氟卡尼 醋酸氟卡尼片 高效液相色谱 含量测定

2024

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子:0.736
ISSN:1672-2981
年,卷(期):2024.22(1)
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