复方头孢克洛片溶出度测定方法研究

目的建立复方头孢克洛片溶出度的测定方法。方法按2005年版《中国药典（二部）》附录溶出度测定法第一法，分别以水、稀盐酸、磷酸盐缓冲溶液等3种溶出介质进行溶出试验，采用高效液相色谱（HPLC）法测定溶出介质中头孢克洛的质量浓度。结果头孢克洛质量浓度在100-800μg／mL范围内与峰面积具有良好的线性关系，平均回收率为99．89％，RSD=1．11％（n=9）；复方头孢克洛片45min时的溶出量大于标示量的90％。结论所建立的溶出度测定方法简单、准确、可靠，可作为复方头孢克洛片的质量控制方法。

Study on Solubility Test of Compound Cefaclor Tablets

Objective To study and establish a method for testing the solubility of Compound Cefaclor Tablets. Methods According to Method 1 in Chinese Pharmacopeia （2005）, Compound Cefaclor Tablets were dissolved in water, hydrochloric acid and the buffered solution of phos- phate（PBS） as dissolution mediators respectively, and the concentration of cefaclor in dissolutions were determined with HPLC. Results The linear correlation of cefaclor was within the range of 100 - 800 ~g/mL. The average recovery rate was 99.89% and RSD was 1, 11%. The solubility was more than 90% in 45 rain. Conclusion The method is simple, accurate and. reliable, which can be made as the standard to control the quality of Compound Cefaclor Tablets.