HPLC法测定盐酸甲氧明有关物质

Determination Related Substances of Methoxamine Hydrochloride by HPLC

本研究建立了HPLC法同时测定盐酸甲氧明中7种有关物质的含量。以XB-C18(250 mm×4.6 mm,5μm)色谱柱;庚烷磺酸钠溶液-甲醇-乙腈为流动相梯度洗脱;柱温为35℃;进样量为10μL、检测波长为226 nm、流速为1.0 mL/min。结果显示专属性试验与耐用性试验项下盐酸甲氧明各有关物质的分离度均不小于1.5;线性与范围试验项下各有关物质的回归方程的R值均不小于0.995,浓度与峰面积呈良好的线性关系;各有关物质的回收率均在98.9%~106.7%之间,回收率的RSD均不大于3%;定量限和精密度均符合要求。所建立的HPLC法可用于盐酸甲氧明中有关物质含量的检验。

To establish a HPLC method for the determination of related substances in methoxamine hydrochloride.The determination was performed on a Ultimate XB-C18(250 mm×4.6 mm,5μm)column with a gradient elution system of sodium heptane sulfonate solution-methanol-acetonitrile at the flow rate of 1.0 mL/min.The column temperature was 35℃,the detection wavelength was set at 226 nm,and,and sample size was 10μL.The resolutions of related substances in methoxamine hydrochloride under the specificity and robustness were not less than 1.5.The R values of regression equations of related substances under the linear and range were not less than 0.995,and the concentration showed a good linear relationship with the peak area.The recoveries of the related substances ranged from 98.9%to 106.7%.The quantitative limit and precision were met the requirements.The HPLC method established can be applied to the determination of related substances in methoxide hydrochloride.