HPLC法测定布洛芬注射液中精氨酸的含量

Determination of arginine in Ibuprofen Injection by HPLC

目的建立一种测定布洛芬注射液中精氨酸含量的HPLC法。方法采用因子设计优化色谱条件。采用Venusil XBP-CN(250mm×4.6 mm,5μm)氰基柱;流动相:磷酸盐溶液(磷酸调pH至3.3)-乙腈(30∶70);检测波长:199nm;流速:1mL.min-1;柱温:30℃;进样量:5μL。结果精氨酸质量浓度在0.4～1.0 mg·mL-1范围内呈良好的线性关系(r=0.999 5),精密度、重复性和稳定性实验的RSD分别为0.28%,0.37%和0.46%(n=6),平均回收率为100.2%,RSD为0.55%。结论该方法准确,简单,快速,重复性好,可用于布洛芬注射液中精氨酸的含量测定。

Objective To establish an HPLC method for the determination of arginine in Ibuprofen Injection. Methods A 23 factorial experiment design was employed in optimiz!ng the chromatographic parameters. The separation of arginine was performed on a Ve- nusil XBP-CN column （250 mm×4.6 mm,5 μm） with pH 3.3 phosphate buffer-acetonitrile （ 30 ： 70） mixture as the mobile phase at a flow rate of 1.0 mL · min^-1 and UV detection at 199 nm. The column temperature was set at 30 ℃ and volume of injection was 5 μL. Results Good linearity was obtained in the ranges of 0.4-1.0 mg · mL^-1 for arginine with the correlation coefficient （r） of 0. 999 5. The relative standard deviations （RSDs） of precision,repeatability and stability were 0.28% ,0.37% and 0.46% （n=6） ,respectively. The average recovery was 100.2% with RSD of 0. 55%. Conclusions This method is accurate, simple and quick,repeatable and suitable for the determination of arginine in Ibuprofen Injection.