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Determination of disodium edetate in Netilmicin Sulfate Injection by HPLC
Author(s): 
Pages: 23-26
Year: Issue:  1
Journal: Qilu Pharmaceutical Affairs

Keyword:  硫酸奈替米星注射液依地酸二钠含量;
Abstract: 目的 采用高效液相色谱法考察硫酸奈替米星注射液中依地酸二钠的含量.方法 以Agilent Zorbax-C18(4.6 mm×250 mm,5μm)为色谱柱;以(四丁基氯化铵2.4 g+醋酸钠4 g+990 mL水溶解,冰醋酸调pH至4.0,加水稀释至1 L)为A相,B相为乙腈-A相(6:4),流速为1.0 mL?min-1,检测波长为350 nm.结果 依地酸二钠线性范围为15~62.5μg?mL-1,相关系数为0.9999;平均回收率为102.5%,RSD为1.19%(n=6).16批次硫酸奈替米星注射液中的依地酸二钠含量均符合规定.本方法与滴定方法测得3批依地酸二钠原料含量无显著差异.结论 该方法专属性强,重复性好,适用于硫酸奈替米星注射液中依地酸二钠的质量控制.
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