HPLC测定克拉霉素分散片中克拉霉素的含量

Determination of Clarithromycin in Clarithromycin Dispersible Tablets by HPLC

目的 建立用HPLC测定克拉霉素分散片中克拉霉素的含量的方法。方法 以Hypersil ODS2（4．6mm×200mm，5μm）为分析柱，以磷酸盐缓冲液-乙腈（600：400）为流动相；检测波长为210nm；流速为每分钟1．0ml；柱温45℃。结果克拉霉素在0．09—1．42mg／ml浓度范围内有良好的线性关系（r=0．9996），平均回收率约为98．6％，RSD为1．5％。结论 本方法操作简便，结果准确可靠，可用于克拉霉素分散片的含量测定。

Objective To develop a method of HPLC for determination of clarithromycin in clarithromycin dispersible tablets. Methods The method employed a Hypersil ODS 2 column with sodium acetate buffer as the mobile phase （600： 400）. The wavelength of UV detection was 210 nm. The flow rate was 1.0 ml/min with the column temperature at 45℃. Results The linear rang was 0.09 - 1.42 mg/ml for Clarithromycin. The average recovery rate was 98.6% with RSD 1.5%. Coneluslon The proposed method is simple and accurate. It is available to the quality control of clarithromycin dispersible tablets.