气相色谱法测定羟基喜树碱-粉防己碱脂质体中氯仿残留量

Determination of Chloroform Residual in the Compound Liposomes of Hydroxycamptothecine and Tetrandrine by Gas Chromatography

目的:采用气相色谱法检测羟基喜树碱-粉防己碱脂质体内氯仿残留量。方法:采用KB-50型毛细管柱(30m×0.25mm,0.25μm),ECD检测器,以二氯甲烷为内标物,测定羟基喜树碱-粉防己碱脂质体中氯仿的残留量。结果:氯仿在0.59～23.68μg·mL^(-1)浓度范围内与其峰面积积分线性关系良好,平均加样回收率均≥95.14%,测得三批样品的氯仿残留量均符合规定。结论:经方法学验证,该检测方法准确可靠,适用于羟基喜树碱-粉防己碱复方脂质体中氯仿残留量的测定。

Objective：To determine the contents of chloroform residual in the compound liposomes of Hydroxycamptothecine and Tetrandrine. Methods： Use gas chromatography whose column type is KB-50（ 30m × 0.25mm , 0.25μm） with electron capture de tector to determine the contents of chloroform residual and the methylene chloride is be used as internal standard substance in the process of detection. Results：There was a good linearity between peak area and concentration within the concentration range of 0.59 -23.68μg·mL-1. The average recovery are more than 95. 14% and the chloroform residual of three batches of samples complied with the specification requirements. Conclusion： The method is reliable and accurate and it can be used in the determination of chloroform residual in the compound liposomes of Hydroxycamptothecine and Tetrandrine through methodology validation.