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高效液相色谱法测定氟康唑胶囊中主药及有关物质的含量
引用本文:刘彩虹,刘俊芳,王丽. 高效液相色谱法测定氟康唑胶囊中主药及有关物质的含量[J]. 中国药房, 2006, 17(16): 1259-1260
作者姓名:刘彩虹  刘俊芳  王丽
作者单位:河南科技大学第一附属医院,洛阳市,471003
摘    要:目的:建立以高效液相色谱法测定氟康唑胶囊中主药及有关物质含量的方法。方法:色谱柱为SpherisorbC18,流动相为磷酸盐缓冲液-甲醇(55∶45),检测波长为260nm,流速为1·0ml/min,柱温为室温。结果:样品中主药与有关物质分离良好,且3批样品中有关物质总含量均低于1·0%;氟康唑检测浓度在0·05~0·25mg/ml浓度范围内与峰面积积分值线性关系良好(r=0·9999),平均回收率为99·8%(RSD=0·49%)。结论:本方法操作方便、结果准确、专属性强、重现性好,可用于氟康唑胶囊的含量测定及有关物质的检查。

关 键 词:氟康唑胶囊  高效液相色谱法  有关物质  含量  测定
文章编号:1001-0408(2006)16-1259-02
收稿时间:2006-05-08
修稿时间:2006-06-08

Determination of Fluconazole and the Related Substances in Fluconazole Capsule by HPLC
LIU Caihong,LIU Junfang,WANG Li. Determination of Fluconazole and the Related Substances in Fluconazole Capsule by HPLC[J]. China Pharmacy, 2006, 17(16): 1259-1260
Authors:LIU Caihong  LIU Junfang  WANG Li
Abstract:OBJECTIVE:To establish an HPLC method for the determination of fluconazole and the related substances in fluconazole capsule.METHODS:The determination was performed on Spherisorb C 18 column at room temperature.The mobile phase consisted of phosphate buffer solution-methanol(55∶45)with a flow rate of1.0ml/min and detective wavelength at260nm.RESULTS:Fluconazole and the related substances in samples were well separated,and the total contents of the related substances in3batches samples were all below1.0%.The linear range of fluconazole was0.05~0.25mg/ml(r=0.9999);the average recovery was99.8%(RSD=0.49%).CONCLUSION:The established method is specific,convenient,accurate and re-producible,and suitable for the determination of fluconazole and the related substances in fluconazole capsule.
Keywords:Fluconazole capsule    HPLC   Related substance   Content   Determination
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