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梯度洗脱HPLC测定克拉霉素缓释片的有关物质
引用本文:林玲,施洁明.梯度洗脱HPLC测定克拉霉素缓释片的有关物质[J].中国药学杂志,2008,43(18):1424-1425.
作者姓名:林玲  施洁明
作者单位:广州市药品检验所 广州 51160
摘    要: 目的建立梯度洗脱HPLC测定克拉霉素缓释片的有关物质。方法采用kromasil C18(4.6 mm×150 mm,5μm)色谱柱,0.476%磷酸二氢钾溶液(用1 mol·L-1磷酸调pH至4.4)为流动相A,乙腈为流动相B,梯度洗脱,流速1.1mL·min-1,检测波长205 nm,柱温40℃。结果克拉霉素在1.73~17.31 mg·L-1内,浓度与峰面积呈良好线性,r=0.999 9。结论本法简便,准确,可定量测定克拉霉素缓释片的有关物质。

关 键 词:梯度洗脱高效液相色谱法  克拉霉素缓释片  有关物质
收稿时间:2008-02-17;

Determination of Related Substances in Clarithromycin Extended Release Tablets by HPLC with Gradient Elution
LIN Ling,SHI Jie-ming.Determination of Related Substances in Clarithromycin Extended Release Tablets by HPLC with Gradient Elution[J].Chinese Pharmaceutical Journal,2008,43(18):1424-1425.
Authors:LIN Ling  SHI Jie-ming
Institution:Guangzhou Institute for Drug Control,Guangzhou 510160,China
Abstract:OBJECTIVE To establish a HPLC method for the determination of the related substances of clarithromycin extended release tablets.METHODS The separation was performed on a kromasil C18(4.6 mm×150 mm,5 μm)as the column.The mobile phase consisted of 0.476% potassium dihydrogen phosphate solution(adjusted pH to 4.0 with 1 mol·L-1 phosphoric acid)as mobile phase A and acetonitrile as mobile phase B.Gradient elution was used.The flow rate was 1.1 mL·min-1.The detection wavelength was 205 nm.The column temperature was 40 ℃.RESULTS The calibration curve was linear within the range of 1.73~17.31 mg·L-1 for clarithromycin(r=0.999 9).CONCLUSION This method was found to be simple and accurate for the determination of related substances in clarithromycin extended release tablets.
Keywords:gradient elution  HPLC  clarithromycin extended release tablets  related substances
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