青蒿琥酯中二氯甲烷残留量的检测方法研究

Determination of Dichloromethane Residual in Artesunate by Headspace GC

目的建立青蒿琥酯中二氯甲烷残留量的检测方法。方法采用毛细管顶空气相色谱法,以外标法计算含量。结果二氯甲烷进样量在0.06～6mg范围内,与峰面积呈良好的线性关系(r=0.9996),最小检出量为15μg,平均回收率为98.6%,RSD为1.3%。结论顶空气相色谱法简便、灵敏、准确,适用于青蒿琥酯中二氯甲烷残留量的检测。

Objective To establish a method for determining diehloromethane residual in artesunate. Methods The dichloromethane residual in artesunate was determined by headspace GC. The assay of dichloromethane residual was calculated by external standard method. Results There was a good linear relationship in the rang of 0.06-6 mg （r=0.999 6）.The average recovery rate and RSD were 98.6% and 1.3% （n = 5）,respectively. Conclusion The method is easy,sensitive,accurate and can be used for quality control.