摘要
目的建立阿司匹林单硝酸异山梨酯复方缓释片中阿司匹林和单硝酸异山梨酯含量及有关物质检测的高效液相色谱法。方法采用Thermo ODS-2 Hypersil(4.6 mm×200 mm,5μm)色谱柱,以0.02 mol.L-1的磷酸二氢钾溶液-甲醇-磷酸(70∶30∶0.1)为流动相,流速1.0 mL.min-1,柱温为40℃,检测波长为225 nm。结果阿司匹林和单硝酸异山梨酯分别为浓度在15.06～120.48μg.mL-1和12.09～96.72μg.mL-1范围内线性关系良好,平均回收率分别为99.55%和99.12%,RSD分别为0.58%和0.54%。结论建立的高效液相色谱法可以同时测定复方缓释片中阿司匹林和单硝酸异山梨酯的含量和有关物质,该方法准确度和精密度高,适合应用于该制剂的质量控制。
Objective To establish an HPLC method for the determination of asprin,isosorbide mononitrate and its related substances in Asiprin and Isosorbide Mononitrate Sustained - release Tablets. Methods Thermo ODS - 2 Hypersil （ 4.6 mm × 200 mm,5 um） was adopted with 0.02 mol . L -1 potassium dihydrogen phosphate - methanol - phosphate （ 70： 30：0.1 ） as the mobile phase and the flow rate was 1.0 mL . min - 1. The column temperature was 40 ℃ and the detection wavelength was 254 nm. Results The linear range of aspirin and isosorbid mononitrate were 15.06 - 120.48 ug . mL-1 and 12.09 - 96.72 ug . mL-1 respectively and the average recoveries were respectively 99.55 % and 99.12% with RSD of 0.58% and 0.54%. Conclusion The established HPLC method can simultaneously determine asprin,isosorbide mononitrate and its related substances. This method was accurate with high precision and it was suitable for the quality control of Asiprin and Isosorbide Mononitrate Sustained - release Tablets.
出处
《齐鲁药事》
2012年第4期217-218,220,共3页
qilu pharmaceutical affairs
