摘要
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(150 mm×4.6 mm,5μm),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1.0 mL·min^(-1),检测波长为300 nm,柱温为30℃。结果 醋酸氟卡尼在196.0~588.0μg·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。
Objective To determine the content of flecainide acetate tablets.Methods High performance liquid chromatography(HPLC) was used with an Alltima C18 column(150 mm×4.6mm,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.
作者
徐硕
邝咏梅
徐文峰
金鹏飞
XU Shuo;KUANG Yong-mei;XU Wen-feng;JIN Peng-fei(Department of Pharmaceutical Sciences,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing Key Laboratory of Assessment of Clinical Drug Risks and Individualized Application(Beijing Hospital),Beijing 100730)
出处
《中南药学》
CAS
2024年第1期204-208,共5页
Central South Pharmacy
