复方盐酸二甲双胍/沙格列汀渗透泵控释片的含量测定结果分析  

Analysis of Content Determination of Compound Metformin Hydrochloride and Saxagliptin Osmotic Pump controlled Release Tablets

作　　者：张圣杰 ZHANG Shengjie(Department of Pharmacy,Changping District Hospital of Traditional Chinese Medicine,Beijing 102200,China)

机构地区：[1]北京市昌平区中医医院药剂科,北京102200

出　　处：《临床研究》2020年第7期17-19,共3页Clinical Research

摘　　要：目的 分析高效液相色谱法(HPLC)对复方盐酸二甲双胍(MH)/沙格列汀(SG)渗透泵控释片的有关含量测定结果.方法 以UItimateXB-CN作为色谱柱,将0.01mol/L磷酸二氢钾溶液-乙腈(15:85)作为流动相,以208nm作为检测波长,流速设置为1.0mL/min,维持30℃的柱温,进样量为20μL.结果 MH与SG分别在50.0~150.0μg/mL、0.5~1.5μg/mL的浓度范围内与峰面积存在良好的线性关系(r=0.9998、0.9992).MH平均回收率99.5%,RSD为0.57%,SG平均回收率100.2%,RSD为1.19%.生产批号为20150711、20150803、20150806的MH/SG渗透泵片中MH、SG标示含量分别为99.2%、97.1%,99.3%、98.5%,98.7%、97.4%.结论 采用HPLC法应用于复方MH/SG渗透泵控释片的有关含量测定中价值较高,结果准确可信,可作为复方MH/SG渗透泵控释片的质量控制有效手段之一.Objective To analyze the content determination of compound metformin hydrochloride(MH)/saxagliptin(SG)osmotic pump-controlled release tablets by high-performance liquid chromatography.Methods Using UItimate XB-CN as column,0.01 Mol/L potassium dihydrogen phosphate solution acetonitrile(15:85)was used as mobile phase and 208 nm was used as detection wavelength,the flow rate was set to 1.0 ml/min,the column temperature was maintained at 30°C,and the injection volume was 20μL.Results There was a good linear relationship between MH and SG in the concentration range of 50.0~150.0μg/mL and 0.5~1.5μg/mL,respectively(r=0.9998,0.9992).The average recovery of MH was 99.5%,RSD was 0.57%,and that of SG was 100.2%,RSD was 1.19%.The labelled contents of MH and SG in the production batches of MH/SG osmotic pump tablets with batch number 20150711,20150803,20150806 were 99.2%,97.1%,99.3%,98.5%,98.7%and 97.4%,respectively.Conclusion The HPLC method has high value in the determination of MH/SG osmotic pump controlled-release tablets.The results are accurate and reliable,and can be used as an effective method for the quality control of MH/SG osmotic pump controlled-release tablets.

关 键 词：盐酸二甲双胍 沙格列汀 渗透泵控释片 含量 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]