HPLC和UV法测定盐酸吗啉胍片的含量及溶出度的比较研究  

Comparative Study on the Determination of Content and Dissolution of Moroxydine Hydrochloride in Morpholine Hydrochloride Tablets by HPLC and UV

作　　者：孔凡建 龙树艳 KONG Fan-jian;LONG Shu-yan(Yuxi Food and Drug Control Institute,Yuxi 653100,China;Dali University,Dali 671000,China)

机构地区：[1]玉溪市食品药品检验所,云南玉溪653100 [2]大理大学,云南大理671000

出　　处：《海峡药学》2021年第5期74-76,共3页Strait Pharmaceutical Journal

摘　　要：目的建立HPLC法测定盐酸吗啉胍片的含量和溶出度,同时测定结果与UV法进行比较分析。方法采用ZORBAX Extend-C 18色谱柱(4.6×150 mm,5μm),柱温:30℃,流动相:乙腈-0.02 moL·L-1庚烷磺酸钠溶液(15∶85),流速:1.0 mL·min^(-1),进样量:20μL,检测波长:237 nm。结果盐酸吗啉胍浓度在10~100μg·mL^(-1)范围内,线性关系良好(r=0.9999,n=5),平均回收率为99.2%,RSD为1.3%(n=9)。结论HPLC法比UV法测得的样品含量及溶出量稍高,HPLC法精密度高,专属性较强,更适合作为盐酸吗啉胍片的质量分析。OBJECTIVE To establish a method for the content and dissolution determation of Morpholine Hydrochloride in Morpholine Hydrochloride Tablets and the results were compared with the UV method.METHODSThe ZORBAX Extend-C_(18)(4.6×150 mm, 5 μm) column was used.The column temperature was 30 ℃.The mobile phases consisted of acetonitrile and 0.02 mol·L^(-1) sodium heptanesulfonate solution(15∶85).The flow rate was 1.0 mL·min^(-1).The injection volume was 20 μL and the detection wavelength was at 237 nm.RESULTS The linear ranges of Morpholine Hydrochloride was at 10~100 μg·mL^(-1)(r=0.9999,n=5).The average recovery was 99.2% with a RSD of 1.3%(n=9).CONCLUSION The content and dissolution of sample was slightly higher than that of UV by HPLC.The method is accurate, strong specificity and it was more suitable for the quality analysis of Moroxydine Hydrochloride in Moroxydine Hydrochloride Tablets.

关 键 词：HPLC法 UV法 盐酸吗啉胍片 含量 溶出度 

分 类 号：R927[医药卫生—药学]