GC法检测泰乐菌素中残留乙酸乙酯的含量

Determination of Residual Ethyl Acetate Content in Tylosin Base By GC

关键词:  泰乐菌素  气相色谱  乙酸乙酯

Key words:  tylosin base  GC  ethyl acetate

摘要:

采用气相色谱（GC）法检测泰乐菌素中残留乙酸乙酯的含量，控制乙酸乙酯在药品中的溶剂残留。水做溶剂，正丁醇为内标物，DB-WAX 30 m?0.25 mm I.D.，0.25 μm毛细管柱，氮气为载气，火焰离子检测器，柱温75 ℃，内标法检测泰乐菌素中乙酸乙酯的含量。检测乙酸乙酯的回收率为95.55%～105.00%，达到验证要求，在4～20 μg/mL浓度范围内线性关系良好(r=0.9999)。该方法简便、准确、分离度好，可用于检测泰乐菌素原料中乙酸乙酯的溶剂残留。

Abstract:

This essay aimed to determine residual ethyl acetate content in tylosin base by GC, which can help to control the residual ethyl acetate in pharmaceuticals. Water was used as solution, n-butanol as the internal standard. The gas chromatography was carried out by a DB-WAX 30 m?0.25 mm I.D.,0.25 μm capillary column, nitrogen as the carrier gas, FID as the detector, and the column temperature was set 75 ℃ using the internal standard method. The recovery rate of ethyl acetate was in the range of 95.55%～105.00% which complied with the validation standard. Moreover, in the concentration of 4～20 μg/mL, the r was 0.9999 and linearity was well. The method was simple, accurate and separable, which can be used to determine the residual ethyl acetate in tylosin base API.