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目的:建立高效液相色谱法测定丁酸氯维地平脂肪乳注射液有关物质的方法。方法:采用Symmetry shield RP18色谱柱(150 mm×4.6 mm,3.5μm),流动相为50 mmol·L-1磷酸二氢钠溶液(稀磷酸调节p H值至4.0)-乙腈-甲醇(40∶25∶35),流速为1.0 m L·min-1,检测波长为220 nm,柱温为30℃。结果:丁酸氯维地平与各相关杂质分离良好,辅料不干扰测定,在0.40~2.49μg·m L-1范围内,丁酸氯维地平浓度与峰面积呈良好的线性关系,线性关系曲线为A=53 239C-92.246(r=0.999 8,n=6),氯维地平的定量限为100 ng·m L-1(相对浓度0.04%)。结论:本方法操作简便准确,灵敏度高,适用于丁酸氯维地平脂肪乳注射液有关物质检查。
Objective: To establish a HPLC method for the determination of clevidipine butyrate butyrate injection related substances. METHODS: Symmetry shield RP18 column (150 mm × 4.6 mm, 3.5 μm) was used. The mobile phase consisted of 50 mmol·L-1 sodium dihydrogen phosphate solution (dilute phosphoric acid adjusted p H to 4.0), acetonitrile-methanol 25:35). The flow rate was 1.0 m L · min-1, the detection wavelength was 220 nm and the column temperature was 30 ℃. Results: The separation of clevidipine butyrate and related impurities was good and the excipients did not interfere with the determination. The concentration of clevidipine butyrate in the range of 0.40 ~ 2.49μg · m L-1 showed a good linear relationship with the peak area. The linear relation curve The limit of quantification for clevidipine was 100 ng · m L -1 (relative concentration 0.04%) for A = 53 239C-92.246 (r = 0.999 8, n = 6). Conclusion: The method is simple, accurate and sensitive. It is suitable for the related substances inspection of clevidipine butyrate butyrate injection.