High speed liquid chromatography for in-process control of rifabutin

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• 作者：Blanco Gomis ; Domingo ; Sá ; nchez Nú ; ñ ; ez ; Noé ; André ; s Garcí ; a ; Elena ; et. al.
• 关键词：High speed HPLC ; In-process control ; Rifabutin
• 刊名：Analytica Chimica Acta
• 出版年：2005
• 期刊代码：2_00032670
• 类别：ch
• 出版时间：February 21, 2005
• 卷：531
• 期：1
• 页码：105-110
• 文件大小：106 K

摘要

A fast HPLC method has been developed for simultaneous determination of rifabutin and its synthesis precursors. The analytes are separated in 1.8min by means of a Kromasil 100 C₁₈ column (50mm×2.1mm i.d., 3.5μm) at 30°C. The mobile phase (A: 5mM KH₂PO₄ adjusted to pH 6.5 with KOH; B: acetonitrile) was pumped at a flow rate of 0.4mlmin⁻¹ according to the fast gradient mode: 0min, 58%B; 0–0.4min, 95%B. Detection was by ultraviolet absorbance at 275nm. The method was validated in accordance with the International Conference on Harmonisation (ICH) guidelines and good accuracy, intermediate precision (≤4.6%) and linearity in the range 5–50mgl⁻¹ were observed for all compounds. This method is sensitive (limits of detection ranged between 0.1 and 0.3mgl⁻¹) and selective to quantify rifabutin and its synthesis precursors and could be used for in-process control.