HPLC法测定长春西汀注射液的有关物质  

Determination of Related Substances in Vinpocetine Injection by HPLC

作　　者：邓丽[1] 汪秋兰[1] 王世民 施春阳[1] 方建国[1] 王文清[1] 

机构地区：[1]华中科技大学同济医学院附属同济医院药学部,武汉430030 [2]武汉华龙生物制药有限公司

出　　处：《中国药师》2016年第11期2182-2185,共4页China Pharmacist

摘　　要：目的:建立测定长春西汀注射液有关物质的方法。方法:采用高效液相色谱法。色谱柱Inert Sustain C_(18)(250 mm×4.6 mm,5μm),检测波长:280 nm;流动相:0.2 mol·L^(-1)醋酸铵溶液-乙腈(40∶60),流速:1.0 ml·min^(-1);柱温:30℃,进样量:10μl。结果:长春西汀主峰与各杂质峰均能良好的分离。杂质A、B、C和D分别在0.276~5.520,0.283~5.660,0.269~5.380,0.282~5.640μg·ml^(-1)浓度范围内具有良好的线性关系,r分别为1.000 0,1.000 0,0.999 9,0.999 9。平均回收率分别为100.5%,100.7%,100.04%,99.9%(RSD分别为1.35%,0.99%,1.13%,1.10%,n=9)。结论:该方法具有较高的专属性、灵敏度、和精密度,能够有效控制长春西汀注射液中的有关物质。Objective： To establish a method for the determination of related substances in vinpocetine injection. Methods： An HPLC method was adopted. An InertSustain C18（250 mm×4.6 mm,5μm） column was used with the mobile phase consisting of 0.2 mol·L^-1 ammonium acetate solution-acetonitrile （40：60） at the flow rate of 1mol·L^-1 . The detection wavelength was 280 nm, the column temperature was 30℃ and the sample size was 10 p.]. Results： The separation of vinpocetine and its impurities was good. The impurity A ,B,C and D bad good linearity within the range of 0.276-5. 520, 0.283-5. 660, 0.269-5. 380 and 0. 282-5. 640μg·ml^-1, and the correlation coefficient was 1. 000 0,1. 000 0,0,999 9 and 0. 999 9, respectively. The average recovery was 100.52% , 100.73% ,100.04% and 99.90%, and RSD was 1.35% ,0.99% ,1.13% and 1.10%, respectively（n =9）. Conclusion： The specificity, precision and sensitivity of the method all meet the requirements. It can be used for the determination of relative substances in vinpocetine injection.

关 键 词：长春西汀注射液 反相高效液相色谱法 有关物质 

分 类 号：R927.2[医药卫生—药学]