摘要
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。
Objective：To develop a RP-HPLC method for the determination of related substances and content of vinpocetine and glucose 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 ammonium 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 vinpocetine 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 .
出处
《中国药品标准》
CAS
2014年第2期99-103,共5页
Drug Standards of China
