HPLC法测定安乃近注射液中苯甲醇的含量

Determination of Benzyl Alcohol in Metamizole Sodium Injection by HPLC

目的:建立高效液相色谱法测定安乃近注射液中苯甲醇的含量。方法:采用Xtimate C18(250 mm×4.6 mm,5μm)柱,流动相为磷酸盐缓冲液(取磷酸二氢钠6.0 g,加水1 000 ml,加三乙胺1 ml,用氢氧化钠溶液调p H至7.0)-甲醇(75∶25),流速为1.0 ml·min^(-1),检测波长为254 nm,柱温:30℃,进样量:5μl。结果:苯甲醇检测线性范围为76.88~269.08μg·ml^(-1)(r=0.998 5),平均回收率为98.77%(RSD=0.77%,n=9)。结论:该方法准确、重复性好,可用于安乃近注射液中苯甲醇含量的测定。

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 1 ml triethylamine,adjusting p H 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.