摘要
目的建立测定长春西汀注射液中对甲苯磺酸甲酯和对甲苯磺酸乙酯含量的高效液相色谱法。方法色谱柱为Waters ODS2 C18柱(150 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(39∶61,V/V),流速为1.0 m L/min,检测波长为226 nm,柱温为35℃,进样量为20μL。结果对甲苯磺酸甲酯、对甲苯磺酸乙酯质量浓度分别在0.1499~0.5998μg/m L和0.1136~0.4542μg/m L范围内与峰面积线性关系良好(r=0.9999,0.9998),平均回收率分别为98.78(RSD=2.02%,n=6)和99.33%(RSD=1.27%,n=6)。结论该方法简便、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 establish an high-performance liquid chromatography(HPLC)method for the content determination of the methyl p-toluene sulfonate and ethyl p-toluene sulfonate in Vinpocetine Injection.Methods The chromatorgraphic column was C18 column(150 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.1%phosphoric acid solution(39∶61,V/V),the flow rate was1.0 m L/min,the detection wavelength was 226 nm,the column temperature was 35℃,and the injection volume was 20%μL.Results The linear ranges of methyl p-toluene sulfonate and ethyl p-toluene sulfonate were 0.1499-0.5998μg/m L(r=0.9999)and 0.1136-0.4542μg/m L(r=0.9998),respectively.The average recoveries of methyl p-toluene sulfonate and ethyl p-toluene sulfonate were 98.78%(RSD=2.02%,n=6)and 99.33%(RSD=1.27%,n=6),respectively.Conclusion This method is simple and accurate,which can be used for the qualitative and quantitative analysis of methyl p-toluene sulfonate and ethyl p-toluene sulfonate in Vinpocetine Injection.
作者
焦洁
妙苗
王涛
蔡虎
JIAO Jie;MIAO Miao;WANG Tao;CAI Hu(Shaanxi Institute for Food and Drug Control·NMPA Key Laboratory of Drug Microbiological Detection Technology,Xi'an,Shaanxi,China 710065)
出处
《中国药业》
CAS
2021年第10期54-56,共3页
China Pharmaceuticals
基金
陕西省重点研发计划项目[2019SF-075]
陕西省创新能力支撑计划项目[2020PT-041]。
