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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 vinpocetine injection related substances. Methods: Using high performance liquid chromatography. The column Inert Sustain C_ (18) (250 mm × 4.6 mm, 5 μm) was used as the detector. The detection wavelength was 280 nm. The mobile phase consisted of 0.2 mol·L -1 ammonium acetate solution (40:60) ml · min ~ (-1); column temperature: 30 ℃, injection volume: 10μl. Results: The main peak of vinpocetine and impurity peaks were well separated. The impurity A, B, C and D have a good linear relationship in the range of 0.276-5.520,0.283-5.660,0.269-5.380,0.282-5.640μg · ml -1, respectively, r = 1.000 0,1.000 0 , 0.999 9, 0.9999 9. The average recoveries were 100.5%, 100.7%, 100.04% and 99.9%, respectively (RSD 1.35%, 0.99%, 1.13%, 1.10%, n = 9). Conclusion: This method has high specificity, sensitivity and precision, which can effectively control the related substances in vinpocetine injection.