Determination of Benzyl Alcohol in Metamizole Sodium Injection by HPLC / 中国药师

ABSTRACT

Objective: To establish an HPLC method to determine the content of benzyl alcohol in metamizole sodium injection. Methods: The determination was performed on an Xtimate C18(250 mm×4. 6 mm,5 μm)column. Phosphate buffer (dissolving 6. 0 g sodium dihydrogen phosphate in 1000 ml water, adding 1ml triethylamine, adjusting pH to 7. 0 with sodium hydroxide solution) -methanol (75 25) was used as the mobile phase at a flow rate of 1. 0 ml·min-1. The detection wavelength was 254 nm. The column tamprture was 30 ℃ and the sample size was 5 μl. Results: The linear range of benzyl alcohol was 76. 88-269. 08 μg·ml-1( r=0. 998 5)with the average recovery of 98. 77% (RSD=0. 77% ,n=9). Conclusion: The method is accurate and reproducible for the content determination of benzyl alcohol in metamizole sodium injection.