HPLC-RID测定瑞格列奈二甲双胍片中葡甲胺的含量

Determination of Meglumine in Repaglinide and Metformin Hydrochloride Tablets by HPLC-RID

目的建立高效液相色谱仪-示差折光检测器联用(HPLC-RID)测定瑞格列奈二甲双胍片中葡甲胺含量的方法。方法采用阳离子交换色谱柱(4.6 mm×150 mm,5μm),以0.05 mol/L醋酸钠溶液-三氟乙酸(100:0.05)为流动相,流速为1.0 ml/min,柱温30℃。结果葡甲胺在48.3~168.9μg/ml浓度范围内,与峰面积呈良好的线性关系(r=0.9998),平均回收率为99.3%(n=9),RSD为0.50%。结论方法简便、快速、准确可靠,适用于瑞格列奈二甲双胍片中葡甲胺含量测定。

Objective To develop an HPLC-RID quantitative method for the determination of meglumine in Repaglinide and Metformin Hydrochloride Tablets.Methods The cation-exchange chromatographic column(4.6 mm×150 mm,5μm)was adopted.The mobile phase consisted of 0.05 mol/L sodium acetate-trifluoroacetic acid(100:0.05),with the flow rate of 1.0 ml/min;the column temperature was 30℃.Results A good linear correlation was observed within the range of 48.3-168.9μg/ml(r=0.9998)for meglumine.The average recovery(n=9)was 99.3%,with RSD of 0.50%.Conclusion The method was simple,efficient and accurate for the analysis of meglumine.