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机构地区:[1]中国医学科学院.北京协和医学院皮肤病医院药剂科,江苏南京210042
出 处:《中国药业》2016年第23期65-67,共3页China Pharmaceuticals
摘 要:目的建立复方联苯苄唑乳膏中氢化可的松和联苯苄唑含量的高效液相色谱(HPLC)法。方法色谱柱采用Waters Symmetry C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-水,梯度洗脱,流速为1.0 m L/min,检测波长为242 nm。结果氢化可的松进样质量浓度在40-200μg/m L的浓度范围内与峰面积呈良好的线性关系(r=0.999 9),平均回收率为98.48%,RSD为1.07%(n=9);联苯苄唑在40-200μg/m L的浓度范围内与峰面积呈良好的线性关系(r=0.999 9),平均回收率为99.43%,RSD为0.93%(n=9)。结论该方法简便准确,重复性好,可用作复方联苯苄唑乳膏中氢化可的松和联苯苄唑的含量控制。Objective To establish an effective HPLC method for the content determination of hydrocortisone and bifonazole in Compound Bifonazole Cream.Methods The separation was performed on Waters Symmetry C(18)(250 mm×4.6 mm,5μm) with different proportions of methanol-water at a flow rate of 1.0 mL/min with gradient elution,and UV detection was set at 242 nm.Results A good linearity was obtained over the range of 40-200 μg/mL(r= 0.999 9) for hydrocortisone and 40-200μg/mL(r= 0.999 9) for bifonazole,respectively.The average recovery rates of these two components were 98.48%with RSD = 1.07%(n = 9) and 99.43%with RSD = 0.93%(n = 9).Conclusion The method is simple,accurate and reproducible,which can be used for the content control of the preparation.
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