HPLC法同时测定复方单硝酸异山梨酯阿司匹林片含量

Determination of Compound Tablets Isosorbide Mononitrate and Aspirin by HPLC

目的:建立用高效液相色谱同时测定复方单硝酸异山梨酯阿司匹林片中2种组分和主要降解产物水杨酸含量的方法。方法:采用Hypersil BDS C_(18)(250mm×4.6mm,5μm)色谱柱,流动相:0.02mol·L^(-1)磷酸二氢钾溶液-甲醇(60:40,用磷酸调节pH至2.8±0.1),流速1.0mL·min^(-1),检测波长220nm,柱温40℃,进样量10μL。结果:线性范围分别是:单硝酸异山梨酯0.0119～1.19mg·mL^(-1),r=0.9998(n=6);阿司匹林0.01～1.0mg·mL^(-1),r=0.9996(n=6);水杨酸0.01012～1.012mg·mL^(-1),r=0.9985(n=6)。平均回收率:单硝酸异山梨酯>99.0%,RSD为<1.0%;阿司匹林>99.0%,RSD为<0.9%。结论:本法分离度好,快速,简便。适用于复方制剂中3种组分的同时测定,可作为产品的质量控制方法。

Objective: To establish a method for determination of three constitutes in compound Isosorbide Mononitrate Aspirin tablets. Methods: RP - HPLC was used to quantitative analysis. The Hypersil BDS C18 column (250 mm×4.6 mm, 5μm) was used, and mobile phase was composed of 0.02 mol·L-1 potassium dihydrogen phosphate -methanol (40:60, adjust pH to 2.8±0.1 by phosphoric acid). Detection wavelength was at 220 nm, the flow rate was 1.0 mL·min-1, column temperature was at 40℃, the injection volume was 10 uuuuL. Results:: The linear response range from 0.0119-1.19 mg·mL-1 of isosorbide mononitrate ( r = 0.9998,n = 6), 0.01-1.0 mg·mL-1 of aspirin (r = 0.999 6, re = 6), 0.010 12-1.012 mg·mL-1 of salicylic acid ( r = 0.998 5,n =6). The recoveries of isosorbide mononitrate are over 99.0% , RSD is less than 1.0%, the recoveries of aspirin are over 99.0% , RSD is less than 0.9% . Conclusion: The method is simple, accurate, and suitable for the determination of the three constituents in compound tablets.