HPLC用于复方单硝酸异山梨酯阿司匹林缓释片的质量分析

Quality research of compound isosorbide mononitrate sustained release tablets by HPLC

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 :HypersilC18柱 ;甲醇 水 (30∶70 )加 1‰磷酸调节pH值至 3.0为流动相 ;流速为 1mL·min-1;UV检测波长为 2 35nm。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 2 0min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 .9999) ,2 0 .0～ 14 0 .0 μg·mL-1(r=0 .9999)。平均回收率分别为 10 0 .4 % (RSD =0 .6 6 % )和 10 0 .7% (RSD =0 .6 9% )。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。

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 C18 column 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 112.0 μg&middotmL-1 for isosorbide mononitrate (r = 0.999 90, and from 20.0 to 140.0 μg&middotmL-1 for 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.