摘要
目的建立HPLC法测定氨甲环酸片溶出度的检测方法。方法采用十八烷基硅烷键合硅胶柱(C18柱,Diamonsil,4.6mm×250mm,5μm);流动相:0.23%十二烷基硫酸钠溶液(用磷酸调节pH至2.5)-甲醇(60:40);检测波长:220nm;流速:1.0mL·min^-1;进样量:100扯L;柱温:30℃。结果氨甲环酸在29.76~357.12μg·mL^-1具有良好的线性关系(r=0.9999);平均回收率为99.61%,RSD为0.45%(n=9)。结论本法简便、快速、准确、专属性好,为中国药典2010年版氨甲环酸片溶出度的修订提供了依据。
Objective To establish an HPLC methed for the dissolution of tranexamic acid tablets. Methods C18 (Diamonsil, 4. 6 mm×250 mm, 5μm) was used with 0. 23% of sodium laurilsulfate-methanol (60 : 40) as the mobile phase. The detection wavelength was 220 nm. The flow rate was 1.0 mL ·min 1. The temperature was 30 ℃. Resuits The linear range of atorvastatin was 29.76 ~ 357.12 μg· mL 1 (r= 0. 999 9) . The average recover was 99. 61%, with RSD of 0.45% (n=9) . Conclusion The method is simple, rapid and accurate. It provides reference for China Pharmacopoeia (2010) to set a standard for the dissolution of tranexamic acid tablets.
出处
《中南药学》
CAS
2009年第4期280-282,共3页
Central South Pharmacy