用HPLC法同时测定自制复方特比萘酚软膏中3个主药成分的含量
投稿时间:2020-07-28  修订日期:2020-11-04  点此下载全文
引用本文:严佳,宋洪涛,周欣.用HPLC法同时测定自制复方特比萘酚软膏中3个主药成分的含量[J].药学实践杂志,2021,39(3):267~269
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严佳 中国人民解放军联勤保障部队第九〇〇医院药剂科福建 福州 350025  
宋洪涛 中国人民解放军联勤保障部队第九〇〇医院药剂科福建 福州 350025 sohoto@vip.163.com 
周欣 中国人民解放军联勤保障部队第九〇〇医院药剂科福建 福州 350025 fzzyjg@163.com 
基金项目:中国人民解放军联勤保障部队第九〇〇医院临床应用研究专项院内课题(2019L17)
中文摘要:目的 建立同时测定自制复方特比萘酚软膏中3个主药成分含量的HPLC法。方法 色谱柱为ZORBAX SB-C8柱(4.6 mm×250 mm,5 μm),流动相为甲醇-0.1%磷酸溶液(70∶30),柱温:30 ℃,流速:1.0 ml/min,检测波长:248 nm,进样量:10 μl。结果 盐酸特比萘芬在20.4~204.0 μg/ml(r =0.999 7),莫匹罗星在40.4~404.0 μg/ml(r=0.9998),糠酸莫米松在2.02~20.20 μg/ml(r=0.999 7)的浓度范围呈良好的线性关系,加样回收率分别为99.39%、99.21%、99.97%,RSD分别为0.82%、0.59%、0.81%(n=9)。结论 该方法的专属性、重复性良好,可用于自制复方特比萘酚软膏中的特比萘酚、莫匹罗星、糠酸莫米松的含量测定。
中文关键词:复方特比萘酚软膏  含量测定  高效液相色谱法
 
Simultaneous determination of three components in pharmacy compounded terbinafine ointment by HPLC method
Abstract:Objective To establish a method to assay 3 active components in pharmacy compounded terbinafine ointment simultaneously.Methods High performance liquid chromatography (HPLC) equipped with the ZORBAX SB-C8 (4.6 mm×250 mm, 5 μm) was used for the assay. The mobile phase was methanol-0.1% phosphoric acid (70∶30). The flow rate was 1.0 ml/min with the 248 nm detection wavelength, 10 μl injection volume and 30 ℃ column temperature.Results A good linear relationship was observed in the range of 20.4-204.0 μg/ml for terbinafine hydrochloride(r=0.999 7), 40.4-404.0 μg/ml for mupirocin(r=0.999 8), 2.02-20.20 μg/ml for mometasone furoate(r=0.999 7). The average recovery of each detected component in terbinafine ointment was 99.39%, 99.21%, 99.97% with the RSD 0.82%, 0.59%, 0.81%(n=9).Conclusion This method is simple, rapid and accurate. It can be used to detect the content of terbinafine, mupirocin and mometasone furoate in pharmacy compounded terbinafine ointment.
keywords:compound terbinafine ointment  content determination  HPLC
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