HPLC用于复方单硝酸异山梨酯-阿司匹林缓释片的质量分析

 目的建立用HPLC分析复方单硝酸异山梨酯-阿司匹林缓释片质量的方法。方法用高效液相色谱法检测复方单硝酸异山梨酯缓释片中药物的含量和释放度。色谱条件为：Hypersil C₁₈柱；甲醇-水(30∶70)加1‰磷酸调节pH值至3.0为流动相；流速为1 mL·min^-1；UV检测波长为235 nm。以乙腈为溶剂配制对照品溶液及样品溶液。结果复方中两种成分及阿司匹林水解产物水杨酸在20 min内达到良好分离。单硝酸异山梨酯、阿司匹林的线性范围分别为16.0～112.0 μg·mL^-1(r=0.999 9)，20.0～140.0 μg·mL^-1(r=0.999 9)。平均回收率分别为100.4%(RSD=0.66%)和100.7%(RSD=0.69%)。结论本法简便、快速，结果准确，可用于同类药品的质量标准研究和质量检验。

Quality research of compound isosorbide mononitrate sustained release tablets by HPLC

OBJECTIVE To establish a method for the quality analysis of compound isosorbide mononitrate sustained release tablets. METHODS: A HPLC method was developed.The chromatographic conditions included Hypersil C₁₈column and the mobile phase was composed of methanol water(30:70,adjusting pH to 3.0 with 1‰ phosphoric acid).The UV detection wavelength was at 235 nm.Acetonitrile was used as the solvent to substitute alcohol which was used in ChP method. RESULTS: A satisfactory separation within 20 minutes was obtained.A linearity and good correlation coefficient were yielded from 16.0 to 112.0μg·mL^-1for isosorbide mononitrate (r=0.999 9),and from 20.0 to 140.0μg·mL^-1for aspirin (r=0.999 9).The mean recoveries of the two components were 100.4% (RSD=0.66%) and 100.7% (RSD=0.69%),respectively. CONCLUSION: The method appeared to be accurate,rapid and simple.It could be used for the determination of the contents and dissolution of the two components in compound isosorbide mononitrate sustained release tablets and similar pharmaceutical products.