木糖醇注射液有关物质的HPLC法测定  

The Determination of Xylitol Injection Related Substance by HPLC

作　　者：沙吉达[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《海峡药学》2006年第1期65-67,共3页Strait Pharmaceutical Journal

摘　　要：目的建立高效液相色谱法测定木糖醇注射液的有关物质。方法K rom asil色谱柱5μC18(2)250×4.60(Phenom enex),以0.02m o l.L-1磷酸二氢钾溶液(每100mL加入0.44g庚烷磺酸钠,并用磷酸调pH值3.0),进样量:20μL。结果自身对照法测定有关物质,各杂质峰面积的总和,不大于对照品溶液主峰面积的2倍。结论该色谱条件下,可以将本品与异枸体及其它有关物质进行有效分离。OBJECTIVE To establish a high performance liquid chromatography method for determination of Xylitol Injection related substance. METHODS The analytical column was phnomenex Luna 5μ C18 （2）250 × 4, 60μm . The mobil phase was potassium dihydrogen phophate （0.02mol · L^-1 ） （add Sodium 1- Heptanesulfonate 0.44g per ml. adjust the pH to3.0 by phophate）, the injection volume was 20μL. RESULTS sum areas of xylitol injection related substance is no 2 times wider than its control main area. CONCLUSION The method good separtion of xylitol injection and its related substances.

关 键 词：木糖醇注射液 有关物质 HPLC 

分 类 号：R927.2[医药卫生—药学]