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。 |
关键词: 泰乐菌素 气相色谱 乙酸乙酯 |
DOI: |
投稿时间:2013-04-18修订日期:2013-07-22 |
基金项目: |
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Determination of Residual Ethyl Acetate Content in Tylosin Base By GC |
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(Shandong Lukang SHELILE Pharmaceutical CO.,LTD) |
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. |
Key words: tylosin base GC ethyl acetate |