CAJ | 학술논문

目的：建立测定长春西汀葡萄糖注射液中有关物质及含量方法。方法：采用RP-HPLC法，色谱柱C18（4.6 mm ×250 mm，5μm），以乙腈-0.2 mol· L-1醋酸铵溶液（60∶40）为流动相，流量1.0 mL· min-1，检测波长280 nm，柱温30℃，进样量20μL。结果：在选定的色谱条件下，主成分及其有关物质能完全分离，已知杂质与长春西汀的相对响应因子均在0.9～1.1之间；长春西汀在0.0107～0.0305 mg· mL-1范围内浓度与峰面积的线性关系良好（r＝0.9997），平均回收率为99.7％，RSD为0.6％（n＝9），检测限为0.071μg· mL-1。结论：该法专属性强，准确度高，可用于长春西汀葡萄糖注射液中有关物质及含量的测定。
목적：건립측정장춘서정포도당주사액중유관물질급함량방법。방법：채용RP-HPLC법，색보주C18（4.6 mm ×250 mm，5μm），이을정-0.2 mol· L-1작산안용액（60∶40）위류동상，류량1.0 mL· min-1，검측파장280 nm，주온30℃，진양량20μL。결과：재선정적색보조건하，주성분급기유관물질능완전분리，이지잡질여장춘서정적상대향응인자균재0.9～1.1지간；장춘서정재0.0107～0.0305 mg· mL-1범위내농도여봉면적적선성관계량호（r＝0.9997），평균회수솔위99.7％，RSD위0.6％（n＝9），검측한위0.071μg· mL-1。결론：해법전속성강，준학도고，가용우장춘서정포도당주사액중유관물질급함량적측정。
Objective:To develop a RP-HPLC method for the determination of related substances and content of vinpocetine and glu -cose injection.Methods:A C18 column (4.6 mm ×250 mm,5 μm) was used with a mobile phase of acetonitrile -0.2 mol· L-1 am-monium acetate solution (60∶40).The flow rate was 1.0 mL· min-1 , the detection wavelength was 280 nm, the column temperature was 30 ℃and the volume of injection was 20 μL.Results:Related substances were completely separated from the main constituent.Relative response factors were in the range of 0.9-1.1 between the known impurities and vinpocetine.A good linear relation of vinpo-cetine was observed within the range of 0.0107-0.0305 mg· mL-1 ( r=0.9997 ).The average recovery was 99.7%with RSD of 0.6%( n=9).The detection limit of vinpocetine was 0.071 μg· mL-1.Conclusion:The method of precision and specificity can satisfy the requirements.It can be used for the control of related substances and content of vinpocetine for Vinpocetine and Glucose Injection .