土霉素片溶出度测定方法研究

Research on Dissolution Test Method of Oxytetracycline Tablets

目的建立土霉素片溶出度的测定方法。方法采用溶出度测定第二法,以盐酸溶液(9→1 000)为溶出介质,转速为50 r/min,经30 min取样,用紫外分光光度法在354 nm波长处测定土霉素片的溶出量,溶出限度为标示量的75%。结果土霉素质量浓度在6.108～21.378μg/mL范围内与吸光度线性关系良好,r=0.999 8(n=6),平均回收率为101.31%,RSD=0.34%(n=9)。结论该方法简便、准确、重现性好,可用于土霉素片的质量控制。

Objective To establish the method of dissolution determination for Oxytetracycline Tablets.Methods The second method for disso-lution test was used with the hydrochloric acid solution（9→1 000） as the dissolution medium and the rotation speed of 50 r /min,after 30 min sampling,UV spectrophotometry was adopted to measure the dissolved amount of Oxytetracycline Tablets at the wavelength of 354 nm.The dissolu-tion limit was 75% of the labeled amount.Results The mass concentration of oxytetracycline in the range of 6.108-21.378 μg /mL showed the linear correlation,the correlation coefficient r =0.999 8（n =6）,the average recovery rate was 101.31%,RSD =0.34%（n =9）.Conclusion This method is simple,accurate and reproducible,which can be used for the quality control of Oxytetracycline Tablets.