还原型谷胱甘肽片质量标准提高

摘要

Objective:To improve the quality standard of Reduced Glutathione Tablets;modifying identification method and establishing determination method of related substances, dissolution and content. Method:HPLC was adopted with Venusil MP C18 column (4. 6 mm × 250 mm,5 μm),the mobile phase was phosphate solution-methanol (96∶4) and the detection wavelength was 210 nm. Results: Re-duced Glutathione had a good linear relationship within 5-1 034μg·mL-1(r=1. 000 0, n=7), the average recovery was 99. 0% with RSD of 0. 6%. Conclusion:The revised standard can be used preferably for the quality control of Reduced Glutathione Tablets.%目的：：对还原型谷胱甘肽片质量标准进行提高：改进鉴别方法,建立有关物质、溶出度和含量测定的方法。方法：采用反相高效液相色谱法,色谱柱用VenusiL MP C18(4．6 mm ×250 mm,5μm),流动相为磷酸盐溶液-甲醇(96∶4),检测波长210 nm。结果：还原型谷胱甘肽在5~1034μg·mL-1浓度范围内线性关系良好(r=1．0000,n=7),平均回收率为99．0%,RSD=0．6%。结论：标准修订提高后,可更好地用于该制剂的质量控制。