DETERMINATION OF ARBEKACIN SULFATE INJECTION AND ITS RELATED SUBSTANCES BY HPLC USING EVAPORATIVE LIGHT SCATTERING DETECTION

Abstract

A new and simple HPLC-ELSD method for the determination of arbekacin sulfate injection and its related substances was developed. The column was Agilent SB-C₁₈ (250 × 4.6 mm, 5μm). The mobile phase was 200 mM trifluoroacetic acid – acetonitrile (91:9) flow rate was 0.8 mL min⁻¹. The detector used was an Dikma SEDEX 75 ELSD detector. The drift tube temperature was 50°C. The pressure of nebulizing gas was 3.5 bar. Good separation of arbekacin from the main related substances could be achieved. The standard curve was rectilinear in the range of 500 ∼ 2500 μg mL⁻¹ (r = 0.9990). The average recovery of arbekacin is 100.8% (R.S.D = 1.5%, n = 9). The average recovery of dibekacin is 104.7% (R.S.D = 2.5%, n = 9). The limit of detection of arbekacin was 4.5 μg mL⁻¹. The limit of detection of dibekacin was 5.0 μg mL⁻¹. The method is simple and rapid, and the results are accurate and reproducible.

Keywords:

• arbekacin sulfate
• arbekacin sulfate injection
• dibekacin
• HPLC-ELSD

ACKNOWLEDGMENTS

This paper is supported by the Zhejiang province project of analysis and test (2009F70027).