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目的:建立以高效液相色谱法测定硫辛酸缓释片中主药含量的方法。方法:色谱柱为HypersilODS,流动相为乙腈-0.05mol·L-1磷酸二氢钾溶液(45∶55,用磷酸调pH为2.0),流速为1.0mL·min-1,进样量为10μL,检测波长为219nm,柱温为25℃。结果:硫辛酸检测浓度的线性范围为9.99～399.70μg·mL-1(r=0.999);平均回收率为99.17%(RSD=0.40%);日内、日间RSD均小于2.6%。结论:本方法简便、准确,可用于硫辛酸的含量测定。
Objective: To establish a method for the determination of the main drug in lipoic acid sustained release tablets by high performance liquid chromatography. Methods: The chromatographic column was Hypersil ODS. The mobile phase was acetonitrile-0.05mol·L-1 potassium dihydrogen phosphate solution (45:55, adjusted to pH 2.0 with phosphoric acid), the flow rate was 1.0mL · min-1 and the injection volume was 10μL , The detection wavelength was 219nm, the column temperature was 25 ℃. Results: The linear range of lipoic acid was 9.99-399.70μg · mL-1 (r = 0.999). The average recovery was 99.17% (RSD = 0.40%). The intra-day and inter-day RSD were less than 2.6%. Conclusion: The method is simple and accurate and can be used for the determination of lipoic acid.