高效液相色谱法测定硫酸西索米星注射液含量

Determination of Sisomicin Sulfate Injection by HPLC

目的建立高效液相色谱法测定硫酸西索米星注射液含量。方法色谱柱为HypersilODS2(4.6×250mm);流动相为含0.61%庚烷磺酸钠0.1m o l.L-1磷酸二氢钾溶液(用磷酸调pH为2.5)-乙腈(78∶22);流速为1.0mL.m in-1;检测波长为205nm。结果西索米星在进样量0.625μg^7.50μg的范围内与峰面积线性关系良好(r=0.9999);平均回收率为100.20%,RSD为0.54%。结论本法简便快捷,结果准确,重现性好,可用于硫酸西索米星的含量测定。

OBJECTIVE To establish a HPLC method for the determination of sisomicin sulfate injection. METHODS The column was Hypersil ODS2 （4.6 × 250mm）. The mobile phase composed of 0. 61% 1-heptanesulfonic acid sodium salt in 0. 1mol·L^-1KH2PO4 （adjust pH2.5 with phosphoric acid）-acetonitrile （78 = 22）. The flow rate was 1mL· min^-1 ,and column temperature was 40℃. The detection was 205nmo RESULTS There was a good linear relationship between sisomicin and peak area when the sample injection was fron 0. 625μg～7.50μg （r = 0. 9999）. The average recovery was 100. 20% and RSD was 0. 54 %. CONCLUSION This method is simple and believable. It can be effectively used for the quality control of sisomicin sulfate injection.