泰妙菌素中溶剂残留量的测定

Determination of Solvents Residue in Tiamulin Fumarate

采用顶空气相色谱法,检测延胡索酸泰妙菌素中甲醇和乙酸乙酯有机溶剂的残留量。结果表明,甲醇和乙酸乙酯在设定范围内有较好的线性,其相关系数均为1.0000,平均回收率分别为105.7%和109.95%,相对标准偏差分别为1.30%和1.50%。该方法准确灵敏,重现性好,满足药典要求,适用于延胡索酸泰妙菌素原料药中有机溶剂残留量的测定。

The residue of methanol and ethyl acetate in Tiamulin fumarate was measured by headspace gas chromatography. The results showed that methanol and ethyl acetate had good linear characteristics in set- ting range and their correlation coefficients were both 1. 0000. The average recovery rate was 105.7% and 109.95% respectively with the relative standard deviation as 1.3% and 1.5%. In conclusion, the method was accurate and sensitive with good repeatability, and it could meet the requirements of pharmacopeia and was suitable for the residue determination of organic solvents in the raw materials of Tiamulin fumarate.