抗真菌新药盐酸萘替芬及其软膏HPLC质控方法改进优化  

Modified determination of hydrochloride naftifine,a new antifungal medicine,in ointment by HPLC

作　　者：梁贵键[1] 朱莉[1] 张蔚君[1] 张哲峰[2] 吕冬 端裕树 

机构地区：[1]空军总医院药剂科,北京100036 [2]河北省药品检验所,石家庄005511 [3]北京岛津分析中心,北京100029

出　　处：《空军总医院学报》2004年第2期83-86,共4页Journal of General Hospital of Air Force,PLA

摘　　要：目的　找出盐酸萘替芬峰时过长且不稳定的原因并对原新药试行标准进行修订。　方法　利用药物色谱保留行为数据库作指导 ,优选出甲醇 乙酸缓冲盐 (70∶30 )为流动相 ,ZorbaxC18 SB为固定相 ,检测波长 2 5 4nm。　结果　新方法盐酸萘替芬保留时间约为 7min ,降低了流动相 10个百分点的甲醇用量。　结论　经优化后的新内标和流动相 ,通过调节 pH值可适用不同色谱柱的差异 ,具有快速、稳定、准确的优点 ,证实了“碱性药物峰序变动区”新概念在HPLC方法建立中具有较大的实用价值。Objective To locate the cource of the unstable and time consuming peak of hydrochloride naftifine,a new antifungal medicine,in ointment and to modifying the criterion of HPLC method for its determination. Methods The optimization of mobile phase was guided by the database of retention behavior of medicines. The chromatographic conditions included Zorbax C18-SB column and the mobile phase consisting of a mixture of methanol-acetate (70∶30). The detection wavelength was set at 254 nm. Results The retention time in the modified method was 7min with reducing 10% of methanol in mobile phase. Conclusion The modified HPLC method was rapid,stable,feasible and accurate. The value of the new concept,“the reversal region of elution order of basic drugs”,was confirmed in the process of foundation of HPLC methods.

关 键 词：烯丙胺 类似物和衍生物 烯丙胺 分析 软膏 

分 类 号：R914.4[医药卫生—药物化学]