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目的:建立HPLC-ECD法测定复方甲哌卡因注射液中左旋异肾上腺素含量的方法。方法:采用Venusil XBP C_8色谱柱(150 mm×4.6 mm,5μm),流动相为醋酸盐缓冲液(取冰醋酸50ml,庚烷磺酸钠1.2g,乙二胺四醋酸二钠0.04g,加水930ml,用2mol·L~(-1)的氢氧化钠溶液调节pH至3.4,加水稀释至1 000ml)-甲醇(90:10);柱温20～25℃;流速为1.0 ml·min~(-1);电化学检测器检测。结果:左旋异肾上腺素在0.2～10μg·ml~(-1)范围内线性关系良好,r=1.0000(n=6);平均回收率为100.9%,RSD 0.6%(n=9)。结论:方法快速,准确,灵敏,可作为注射液中微量肾上腺素类药物的测定方法。
Objective: To establish a HPLC-ECD method for the determination of compound mepivacaine injection levodisailine content. Methods: Venusil XBP C_8 column (150 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of acetate buffer (50 ml of glacial acetic acid, 1.2 g of heptane sulfonate and 0.04 g of disodium ethylenediaminetetraacetate) Add water 930ml, adjust pH to 3.4 with 2mol·L -1 sodium hydroxide solution, dilute with water to 1 000ml) -methanol (90:10); the column temperature is 20-25 ℃; the flow rate is 1.0 ml · min ~ (-1); electrochemical detector detection. Results: L-isoproterenol had a good linearity in the range of 0.2 ~ 10μg · ml ~ (-1), r = 1.0000 (n = 6). The average recovery was 100.9% with RSD 0.6% (n = 9). Conclusion: The method is rapid, accurate and sensitive and can be used as a method for the determination of trace adrenergic drugs in injection.