克拉霉素缓释片中克拉霉素的反相高效液相色谱法含量测定的方法学考察

Study on Determination of Clarithromycin in Clarithromycin Sustained Release Tablets by RP-HPLC

目的:建立用反相高效液相色谱法测定克拉霉素缓释片中克拉霉素的含量测定方法,并考察其方法学的实用性。方法:采用Hypersil BDS C18色谱柱(200 mm×4.6 mm,5μm)为固定相,流动相为乙腈-0.067 mol/L磷酸二氢钾溶液(40∶60),流速为1.0 mL/min,检测波长为210 nm,柱温为25℃;采用反相高效液相色谱法检测克拉霉素缓释片中克拉霉素的含量。结果:克拉霉素浓度在0.17~0.65 mg/mL范围内呈良好的线性关系(r=0.9998),平均RSD为0.89%,回收率为99.50%;4批克拉霉素缓释片中的平均含量为96.87%。结论:在克拉霉素缓释片质量控制检测中,用反相高效液相色谱法测定克拉霉素的含量,其操作快速、简便,可适用于克拉霉素缓释片的含量测定。

Objective:To establish a method for determination of clarithromycin in clarithromycin sustained release tablets by reversed-phase high performance liquid chromatography(RP-HPLC)and to investigate the practicability of its methodology.Methods:Hypersil BDS C18 column(200 mm×4.6 mm,5μm)was used as the stationary phase and mobile phase was acetonitrile-0.067 mol/L potassium dihydrogen phosphate(40:60).The flow rate was 1.0 mL/min.The detection wavelength was 210 nm and the column temperature was 25℃.The content of clarithromycin in sustained-release tablets was determined by RP-HPLC.Results:Clarithromycin concentration showed a good linear relationship between 0.17 and 0.65 mg/mL(r=0.9998),and the average RSD was 0.89%,and the recovery was 99.50%.The average content of 4 batches of clarithromycin sustained-release tablets was 96.87%.Conclusion:In the quality control of clarithromycin sustained release tablets,RP-HPLC is used to determine the content of clarithromycin.The operation is rapid and simple,and it is suitable for determination of clarithromycin sustained release tablets.