顶空气相色谱法测定头孢哌酮钠他唑巴坦钠中残留有机溶剂  

Headspace Gas Chromatography Determination of Residual Organic Solvents in Cefoperazone Sodium and Tazobactam Sodium

作　　者：孙夏荣 曹玉 李丹 王贞媛 

机构地区：[1]江苏省南京市药品检验所,江苏南京210015

出　　处：《中国药业》2008年第23期32-33,共2页China Pharmaceuticals

摘　　要：目的建立头孢哌酮钠他唑巴坦钠中甲醇、丙酮溶剂残留量的测定方法。方法采用顶空气相色谱法,以去离子水为溶剂,氮气为载气,进样口温度为200℃,检测器温度为250℃。结果甲醇、丙酮的质量浓度分别在37.97～189.84mg/L和63.68～318.4mg/L的范围内与峰面积线性关系良好,r分别为0.9985和0.9991,平均回收率分别为104.20%(RSD=1.6%,n=6)和104.13%(RSD=1.3%,n=6),最低检测限分别为0.21mg/L和0.32mg/L。结论顶空气相色谱法简单、准确,可用于头孢哌酮钠他唑巴坦钠的有机溶剂残留测定。Objective To establish the content determination method for the residual organic solvents of cefoperazone sodium and tazobactam sodium. Methods The samples were injected into Hp- Innowax capillary column （30 m ×0. 32 mm, 0. 5 μm） by headspace sampler and analyzed with FID detector. The samples were dissolved in water. The carrier gas used was nitrogen. The injector temperature was 200 ℃. The detector temperature was 250 ℃. Results The quality concentration of 37. 97-189. 84 mg/L for methanol and 63.68-318.4 mg/L for acetone showed the good linear relationship. The correlation coefficients were 0. 998 5 and 0. 999 1, the recovery rates were 104. 20% （ RSD = 1.6% ） and 104. 13% （ RSD = 1.3% ）, and the detecting limits were 0. 21 mg/L, 0. 32 mg/L, respectively. Conclusion The method is simple and accurate, which can be used to determine the organic solvent residue in cefoperazone sodium and tazobactam sodium.

关 键 词：顶空气相色谱法 头孢哌酮钠他唑巴坦钠 溶剂残留 甲醇 丙酮 

分 类 号：R927.1[医药卫生—药学] R978.11