高效液相色谱法测定复方硝酸咪康唑软膏中硝酸咪康唑和丙酸倍氯米松含量

HPLC Determination of the Content of Miconazole Nitrate and Beclometasone Dipropionate in Compound Miconazole Nitrate Ointment

目的建立复方硝酸咪康唑软膏中2种化学药成分的含量测定方法。方法采用反相高效液相色谱法。以C18为色谱柱,以甲醇-0.03mol/L磷酸二氢钾溶液(用磷酸调pH至3.5)(80∶20)为流动相,检测波长为240nm,流速为1.0mL/min。结果硝酸咪康唑在浓度0.5153～4.1220mg/mL范围内有良好线性关系(r=0.9991);丙酸倍氯米松在浓度为1.803～24.040μg/mL范围内有良好线性关系(r=0.9999);硝酸咪康唑的平均回收率为100.60%(n=9),丙酸倍氯米松的平均回收率为99.65%(n=9)。结论所建立的方法简便、准确、重现性好,能有效控制用新工艺制备的软膏的内在质量。

Objective To establish HPLC method for the determination of Compound Miconazole Nitrate Ointment.Methods Chromatographic conditions were as follows：column,Luna C18 ODS （250 mm×4.6 mm,D 5 μm）;mobile phase,methanol -0.03 mol/L potasium dihydrogen phosphate solution （adjusted with H3PO4 to pH3.5）（80∶20）;UV detection,240 nm;flow rate,1.0 mL/min.Results The calibration curves were linear in the range of 0.5153~4.1220 mg/mL for Miconazole Nitrate （r=0.9991） and 1.803～24.040 μg/mL for Beclometasone Dipropionate（r=0.9999）.The average recoveries of Miconazole Nitrate and Beclometasone Dipropionate were 100.60%（n=9） and 99.65%（n=9）,respectively.Conclusion The method is simple,accurate,and have good reproducibility.It was reliable for the quality control of the Ointment.