HPLC测定复方瑞格列奈二甲双胍片光学异构体方法的研究

摘要

目的：建立测定复方瑞格列奈二甲双胍片中左旋异构体的高效液相色谱（HPLC）方法。方法采用手性色谱柱（填料为α-酸性糖蛋白，100 mm×4.0 mm，5μm）；流动相：以1.0 g/L磷酸二氢钾（氢氧化钠调pH 4.7）为流动相A，乙腈为流动相B；流速：1.0 mL/min，梯度洗脱；检测波长：240 nm。结果瑞格列奈左旋异构体与其他峰的分离度良好，检出限为0.75 ng。结论此方法准确，简便，快速，适用于复方瑞格列奈二甲双胍片的质量控制。%Objective To establish an HPLC method for the determination of levoisomer in Repaglinide and Metformin Hydrochloric Acid Tablets. Methods HPLC was performed on a CHIRAL-AGP column (100 mm×4 mm, 5μm). 1.0 g/L potassium dihydrogen phosphate solution adjusted to pH 4.7 with sodium hydroxide was used as mobile A and acetonitrile was used as mobile B. The detection wavelength was set at 240 nm. The flow rate was 1.0 mL/min. Results An excellent separation was achieved for the levoisomer of repaglinide and the other substances. The detection limit was 0.75 ng. Conclusion This method can be accurate, simple, quick and effective for the quality control of Repaglinide and Metformin Hydrochloric Acid Tablets.