High speed liquid chromatography for in-process control of rifabutin

• Published in: Analytica chimica acta 2005-02, Vol.531 (1), p.105-110
• Main Authors: Blanco Gomis, Domingo, Sánchez Núñez, Noé, Andrés García, Elena, Arias Abrodo, Pilar, Bayod Jasanada, Miguel, Dolores Gutiérrez Álvarez, Mª.
• Format: Article
• Language: English
• Subjects: Analytical chemistry; Chemistry; Chromatographic methods and physical methods associated with chromatography; Exact sciences and technology; High speed HPLC; In-process control; Other chromatographic methods; Rifabutin; Spectrometric and optical methods
• ISSN: 0003-2670; 1873-4324
• DOI: 10.1016/j.aca.2004.09.083

A fast HPLC method has been developed for simultaneous determination of rifabutin and its synthesis precursors. The analytes are separated in 1.8 min by means of a Kromasil 100 C 18 column (50 mm × 2.1 mm i.d., 3.5 μm) at 30 °C. The mobile phase (A: 5 mM KH 2PO 4 adjusted to pH 6.5 with KOH; B: acetonitrile) was pumped at a flow rate of 0.4 ml min −1 according to the fast gradient mode: 0 min, 58% B; 0–0.4 min, 95% B. Detection was by ultraviolet absorbance at 275 nm. 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 5–50 mg l −1 were observed for all compounds. This method is sensitive (limits of detection ranged between 0.1 and 0.3 mg l −1) and selective to quantify rifabutin and its synthesis precursors and could be used for in-process control.