梯度洗脱HPLC测定克拉霉素缓释片的有关物质

Determination of Related Substances in Clarithromycin Extended Release Tablets by HPLC with Gradient Elution

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。

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.