采用带紫外检测的高效液相色谱法同时测定复方蒿甲醚片中蒿甲醚和本芴醇的含量。
Simultaneous determination of artemether and lumefantrine in fixed dose combination tablets by HPLC with UV detection.
作者信息
César Isabela da Costa, Andrade Nogueira Fernando Henrique, Antônio Pianetti Gérson
机构信息
Departamento de Produtos Farmacêuticos, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Av. Pres. Antônio Carlos 6627, 31270-901 Belo Horizonte, MG, Brazil.
出版信息
J Pharm Biomed Anal. 2008 Nov 4;48(3):951-4. doi: 10.1016/j.jpba.2008.05.022. Epub 2008 May 28.
This paper describes the development and validation of a HPLC-UV method (210 nm) for the simultaneous quantitation of artemether and lumefantrine in fixed dose combination tablets. The method showed to be linear (r(2)>0.99), precise (R.S.D.<2.0%), accurate (recovery of 101.07% for artemether and 101.58% for lumefantrine), specific and robust. Four batches of artemether-lumefantrine tablets were assayed by the validated method. The artemether contents in the tablets varied from 98.61% to 103.35%, while lumefantrine contents were 97.92-100.48%.
本文描述了一种用于同时定量复方蒿甲醚片（固定剂量复方片剂）中蒿甲醚和本芴醇的高效液相色谱-紫外检测法（210 nm）的开发与验证。该方法显示具有线性（r(2)>0.99）、精密度高（相对标准偏差<2.0%）、准确度高（蒿甲醚回收率为101.07%，本芴醇回收率为101.58%）、专属性强且稳健的特点。采用经过验证的方法对四批蒿甲醚-本芴醇片进行了分析。片剂中蒿甲醚含量在98.61%至103.35%之间，而本芴醇含量为97.92 - 100.48%。
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