注射用长春西汀中两种磺酸酯类基因毒性杂质的测定

Determination of genotoxic impurities of sulfonate esters in vinpocetine for injection

目的建立高效液相色谱法测定注射用长春西汀中对甲苯磺酸甲酯和对甲苯磺酸乙酯的含量。方法采用Waters ODS2 C18(150 mm×4.6 mm,5μm)色谱柱;流动相为乙腈-0.1%磷酸溶液(39∶61);流速为1.0 mL·min^(-1);检测波长为225 nm。结果对甲苯磺酸甲酯在0.15~0.60μg·mL^(-1)与峰面积线性关系良好,平均加样回收率98.9%,RSD=1.2%。对甲苯磺酸乙酯在0.11~0.45μg·mL^(-1)与峰面积线性关系良好,平均加样回收率99.5%,RSD=1.6%。结论本方法简便、准确,可用于长春西汀注射液中对甲苯磺酸甲酯和对甲苯磺酸乙酯的定性和定量分析。

Objective To determine the genotoxic impurities methyl p-toluene sulfonate and ethyl p-toluene sulfonate in vinpocetine for injection by HPLC.Methods The chromatorgraphic conditions adopted were ODS2 C18(150 mm×4.6 mm,5μm),acetonitrile-0.1%phosphoric acid solution(39∶61)was used as the mobile phase in gradient elution mode at the flow rate of 1.0 mL·min^(-1).The detection wavelength was 225 nm.Results The methyl p-toluene sulfonate showed good linearity at 0.15~0.60μg·mL^(-1),whose average recovery was 98.9%with RSD=1.2%.The ethyl p-toluene sulfonate showed a good linearity at 0.11~0.45μg·mL^(-1),whose average recovery was 99.5%with RSD=1.6%.Conclusion This method is simple,accurate,which can be used for the qualitative and quantitative analysis of methyl p-toluene sulfonate and ethyl p-toluene sulfonate in vinpocetine for injection.