HPLC法和UV分光光度法测定阿奇霉素片溶出度的方法比较

Comparison of HPLC and UV methods in determination of dissolution of azithromycin tablet

目的采用HPLC和UV分光光度法测定阿奇霉素片溶出度,并从中选择适宜的方法。方法高效液相色谱法,采用ODS-50色谱柱,流动相为0.04M磷酸盐缓冲液（pH 11.0）-乙腈（400∶600）,检测波长215 nm,柱温40℃,进样量20μL,溶出介质为磷酸盐缓冲液（pH6.5）,转数为75 r/min,45 min取样。紫外分光光度法以磷酸盐缓冲液（pH6.0）为空白溶液及溶剂,检测波长为（482±2）nm,溶出介质为磷酸盐缓冲液（pH6.0）,转速为100 r/min,45 min取样。结果溶出曲线方程式为：Y=0.001 3X＋0.913,10 min时累计溶出量为92.3%（RSD=1.9%）。回归方程：A=0.007 5C-0.017 1,r=0.999 1。线性范围在17.9-89μg/mL,回收率为99.6%（RSD=0.4%）。结论两种方法都较为准确、简便,测得的溶出效果较好,溶出度结果也基本一致。

Objective To establish an effective and reliable determination for the dissolution of azithromycin tablet through comparing HPLC and UV methods.Methods ODS-50 column was used in HPLC method with phosphate buffer solution（pH 11.0）-acetonitrile（400∶600）as mobile phase.Column temperature was 40 ℃,detective wavelength was 215 nm,and injective volume was 20 μL.Phosphate buffer solution（pH 6.5）was used as dissolution medium.Rotatory speed was 75 rpm,and the sample was taken at 45 min.UV method：phosphate buffer solution（pH 6.0）was used as empty solvent,and detective wavelength was（482±2） nm.Dissolution medium for UV method was phosphate buffer solution（pH 6.0）.Rotatory speed was 100 rpm,the sample was taken at 45 min.Results Linear range was 17.9～89.0 μg/mL,and recovery rate was 99.6%（RSD=0.4%）.The average accumulated dissolution was 92.3%（RSD=1.9%）at 10 min.Conclusion The two methods are equivalent in determining dissolution of azithromycin tablet,and they are simple and accurate with good dissolution effect.