HPLC法测定溴丙胺太林片的含量和有关物质

Determination of the Content and Related Substances in Propantheline Bromide Tablets by HPLC

目的:建立HPLC法测定溴丙胺太林片含量和有关物质的方法。方法:色谱柱:Venusil XBP C_8(150mm×4.6mm, 5μm);流动相:乙腈-磷酸盐缓冲液(取十二烷基硫酸钠17.3g,氢氧化钠5.0g,加水1000ml溶解,用磷酸调节pH至3.5±0.05,加水稀释至2000ml)(54:46);检测波长:254nm。结果:溴丙胺太林在0.003～3.000mg·ml^(-1)范围内线性关系良好(r= 1.000 0);平均回收率为100.2%,RSD=1.1%;各杂质峰的分离度均达到要求。结论:本测定方法准确、灵敏、专属性高,可作为溴丙胺太林片的含量测定和有关物质检查方法。

Objective： To establish an HPLC method to determine the content and related substances in propantheline bromide Tablets. Method： The Venusil XBP Cs column（ 150mm ×4.6mm,5μm）was used, acetonitrile - phosphate buffer （dissolve 17.3g sodium dodecyl sulfate and 5.0g sodium hydroxide in 1000ml water, adjust pH to 3.5 ± 0.05 with phosphoric acid, dilute to 2000ml with water） （54： 46） as the mobile phase,the detection wavelength was 254nm. Result： The calibration curve showed a good linearity over the range of 0. 003 -3mg·ml^-1 ,r = 1. 000 0. The recovery was 100.2% ,RSD = 1.1%. The chromatographic resolutions of each impurity peak complied with the requirement. Conclusion： The method is accurate, sensitive, specific, and suitable for the determination of the content and related substances in propantheline bromide Tablets.