摘要
目的建立反相高效液相色谱法快速测定头孢氨苄片中头孢氨苄的含量。方法采用Bonshell表面多孔壳层色谱柱（3.0×100mm,2.7μm）,参考中国药典2010版二部头孢氨苄片含量测定方法,以水-甲醇-3.86%醋酸钠-4%醋酸溶液（742∶240∶15∶3）为流动相,等度洗脱,流速0.4mL·min-1,柱温30℃,检测波长254nm。结果样品溶液色谱图中显示与对照品溶液色谱图中相同的头孢氨苄色谱峰,且分离度良好。头孢氨苄在1.0-200.0μg·mL-1范围内与峰面积呈良好的线性关系（r=0.9999）;重复性试验的RSD=3.5%（n=6）;平均回收率为101.2%,RSD=2.1%（n=6）。结论该方法快速、简便、灵敏、专属性强。既加快了分析速度,又减少了有机溶剂的使用,可以在药典方法条件下实现头孢氨苄片含量测定的高通量分析。
OBJECTIVE To establish a RP-HPLC method for the fast determination of cefalexin in cefalexin tablets. METHODS The cefalexin was analyzed on a Bonshell superficially porous layer core-shell high performance liquid chromatography column（ 3. 0 × 100 mm,2. 7μm） by a isocratic elution using water-methanol-3. 86% sodium acetate-4% acetic acid（ 742∶240∶15∶3） as the mobile phase according to the 2010 edition of Chinese Pharmacopoeia. With 30℃ column temperature,the flow rate was 0. 4mL·min- 1and the UV detection wavelength was set at254 nm. RESULTS The chromatogram of the sample solution showed the peak of cefalexin which was similar to the reference solution with high resolution. The linear range for the cefalexin was between 1. 0μg·mL- 1and 200. 0μg·mL- 1（ r =0. 9999）,the RSD of repeatability test was 3.5%,the average recovery was 101.2% and the RSD was2. 1%. CONCLUSION The method is rapid,simple,sensitive and high specificity with higher analysis speed and reducing the solvent using. It also can be used in the high throughput experiments under the condition of Chinese pharmacopoeia.
出处
《海峡药学》
2014年第8期59-62,共4页
Strait Pharmaceutical Journal
