HPLC法测定阿尔维林硬胶囊的含量

建立了新的高效液相色谱法测定阿尔维林硬胶囊的含量。以0.01mol/L十二烷基磺酸钠-60%乙腈溶液为流动相(磷酸调节pH=3.0),流速1.5mL/min,紫外检测波长为220nm时,进样量20μL,使用ODS C18(200mm×4.6mm,5μm)为色谱柱对阿尔维林硬胶囊中阿尔维林与其它杂质实现基线分离。实验结果表明浓度在0.15～2.4mg/mL(r=0.999 1,n=5)范围内线性关系良好;平均回收率为:99.60%;最低检测限可达0.75ng;含量检测结果符合标准。本法精密度高,分离效果好,专属性与系统适用性强,可用于枸橼酸阿尔维林硬胶囊含量的测定。

Determination of content of alverine citrate hard capsule by HPLC

A novel method was established for determining the content of alverine citrate hard capsule based on high performance liquid chromatography(HPLC).The determination was accomplished using an ODS C18(200mm×4.6mm,5μm) column and with sodium dodecylsulphate-60% acetonitrile(adjusted the solution with phosphoric acid to pH=3.0) as mobile phase.The flow rate was 1.5mL/min.The detection wavelength was 220nm and the injection volume was 20μL.Under the optional methods,the HPLC method proved to be the linear range of standard curve of the content was 0.15mg/mL~2.4mg/mL(r= 0.999 1,n=5).The average recovery was 99.60%;the lowest detectable limit was 0.75ng.This method has a high precision and a good separated effect,the specificity and system suitability were also good which can be used to determine the content of the alverine citrate hard capsule.