中国药品标准
中國藥品標準
중국약품표준
DRUG STANDARDS OF CHINA
2015年
4期
277-281
,共5页
还原型谷胱甘肽片%质量标准%高效液相色谱法
還原型穀胱甘肽片%質量標準%高效液相色譜法
환원형곡광감태편%질량표준%고효액상색보법
Reduced Glutathione Tablets%quality standard%HPLC
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。
目的：：對還原型穀胱甘肽片質量標準進行提高：改進鑒彆方法,建立有關物質、溶齣度和含量測定的方法。方法：採用反相高效液相色譜法,色譜柱用VenusiL MP C18(4．6 mm ×250 mm,5μm),流動相為燐痠鹽溶液-甲醇(96∶4),檢測波長210 nm。結果：還原型穀胱甘肽在5~1034μg·mL-1濃度範圍內線性關繫良好(r=1．0000,n=7),平均迴收率為99．0%,RSD=0．6%。結論：標準脩訂提高後,可更好地用于該製劑的質量控製。
목적：：대환원형곡광감태편질량표준진행제고：개진감별방법,건립유관물질、용출도화함량측정적방법。방법：채용반상고효액상색보법,색보주용VenusiL MP C18(4．6 mm ×250 mm,5μm),류동상위린산염용액-갑순(96∶4),검측파장210 nm。결과：환원형곡광감태재5~1034μg·mL-1농도범위내선성관계량호(r=1．0000,n=7),평균회수솔위99．0%,RSD=0．6%。결론：표준수정제고후,가경호지용우해제제적질량공제。
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.
