摘要
目的:建立HPLC法测定氟康唑胶囊中的有关物质。方法:以Thermo C18色谱柱为固定相,以0.01 mol.L-1甲酸铵-乙腈为流动相进行梯度洗脱,流速为0.5 mL.min-1,检测波长为261 nm。结果:氟康唑和杂质B、C和D质量浓度分别在2.6～21.1、2.7～53.8、0.9～21.3和2.6～20.8 mg.L-1范围内,其色谱峰面积与质量浓度的线性关系良好;氟康唑和杂质B、C、D的平均回收率分别为99.9%、98.8%、100.0%和99.3%(n=9)。结论:该方法便捷、灵敏、准确,可用于氟康唑胶囊中有关物质的检测。
Objective： To establish a HPLC fluconazole capsules. Methods： The separation eluent composed of 0. 01 mol. L-1 ammonium method for the determination of the related substances in was conducted by using Thermo ClS column with gradient formate and acetonitrile. The flow rate was 0. 5 mL-min- and the UV detection wavelength was 261 nm. Results： The chromatographic peak area and concentration of fluconazole showed a good linear relationship at the range of 2. 6 -21.1 mg-L-1. The chromatographic peak area and concentration of the related substances B, C and D showed good linear relationships at the range of 2.7-53.8 mg.L-1, 0.9-21.3 mg-L-1 and 2.6-20.8 mg-L-1, respectively. The average recovery of fluconazole, the related substances B, C and D was 99.9%, 98.8%, 100.0% and 99.3%, respectively （ n = 9）. Conclusion： The method is convenient, sensitive and accurate. It can be used for the determina- tion of the related substances in fluconazole capsules.
出处
《药学进展》
CAS
2013年第5期230-234,共5页
Progress in Pharmaceutical Sciences
基金
国家科技攻关计划课题(No.2004BA720A34)
