毛细管区带电泳法测定酪丝亮肽及其制剂的含量和有关物质

 目的 建立毛细管区带电泳(CZE)法测定酪丝亮肽及其制剂的含量和有关物质。方法 采用CZE,以O.05 mol·L^-1磷酸盐缓冲液(pH 8.0)为运行缓冲液;运行电压:14 kV;压力进样3.45 kPa,3 s;检测波长:200 nm;毛细管柱温:25℃;以咪唑为内标物。结果在0.001～1.0 mg·mL^-1的范围内,线性关系良好(r=0.999 7);最低检测限为0.1μg·mL^-1;精密度的RSD为0.76％(n=7);制剂的低、中、高加样回收率分别为99.2％,99.3％,98.9％(n=3);主峰和各杂质峰间均能达到很好的分离。结论 该法简便、快速、准确,可用于原料和制剂的含量测定及其有关物质检查。

Studies on CZE determination of tyroserleutide and the related substances in its preparation

OBJECTIVE To establish a capillary zone electrophoresis (CZE) method for determining tyroserleutide and the related substances in its preparation.METHODS In CZE analysis, imidazole was used as the internal standard and 0.05 mol·L^-1 phosphate buffer(pH 8.0)was used as electrolyte buffer.The separation voltage was 14 kV with the detection wavelength at 200 nm.The column temperature was at 25℃ and injection pressure was at 3.45 kPa(3 s). RESULTS The linear range of the method was 0.001～1.0 mg·mL^-1(r=0.9997). The limit of detection was 0.1μg·mL^-1. The precision RSD of tyroserleutide was 0.76% (n=7). The recoveries of the check samples at low, middle, high concentrations were 99.2%, 99.3% and 98.9% (n=3) respectively.The resolution between main peak and impurities was good. CONCLUSION The method is simple,rapid, accurate and can be used to determine tyroserleutide and related substances in its preparation.