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目的:建立以高效液相色谱法测定左卡尼汀片中右旋卡尼汀含量的测定方法。方法:采用phenomenex LUX Cellulose-1(250mm×4.6mm,5μm)色谱柱,流动相为乙腈-0.5mol/L高氯酸钠溶液,梯度洗脱,流速:0.4ml·min-1,检测波长235 nm,柱温:28℃。结果:在本色谱条件下进样量:10μl;右卡尼汀在浓度1.978μg·ml-1~23.741μg·ml-1范围内线性关系良好,加样回收率(n=9)均在80%~120%之间,RSD值均小于5.0%。结论:本方法快速、准确,重复性好。可以满足左卡尼汀片中右旋卡尼汀含量的测定要求。
Objective: To establish a method for the determination of dextran carnitine in levocarnitine tablets by high performance liquid chromatography. Methods: The mobile phase consisted of acetonitrile-0.5mol / L sodium perchlorate solution with gradient elution at a flow rate of 0.4ml · min-1 with a detection wavelength of 235ml · min using a phenomenex LUX Cellulose-1 (250mm × 4.6mm, 5μm) nm, column temperature: 28 ℃. Results: The injection volume under the chromatographic conditions: 10μl; Right concentration of n-carnitine in the range of 1.978μg · ml-1 ~ 23.741μg · ml-1 within a good linear relationship, sample recovery (n = 9) % ~ 120%, RSD values are less than 5.0%. Conclusion: The method is rapid, accurate and reproducible. L-carnitine tablets to meet the determination of dexcitabine content requirements.