甲磺酸非诺多泮注射液HPLC含量测定方法学研究

Study on Methodology for Determination of Fenoldopam Mesylate Injection by HPLC

目的：建立甲磺酸非诺多泮含量测定方法。方法：照高效液相色谱法,以Zorbax SB-Phenyl（苯基）（5μm,250 mm×4.6 mm）为色谱柱,以磷酸盐缓冲液（称取磷酸二氢钾16.33 g,三乙胺2 m L,加水900 m L溶解,用磷酸溶液调p H至2.5）∶甲醇=19∶1为流动相;检测波长为225 nm,柱温为40℃,流速为1.0 m L/min。结果：含量测定方法学研究表明,该方法专属性好;甲磺酸非诺多泮在16.75-83.76μg/m L的浓度范围内与其峰响应值呈良好的线性关系,平均回收率为98.8%（RSD=0.3%）。结论：本方法测定结果准确,精密度高,耐用性良好,可以作为甲磺酸非诺多泮的含量测定方法。

Objective： To establish the method for determination of Fenoldopam mesylate injection. Method： The assay involved an isocratic elution of Fenoldopam in a Agilent SB- Phenyl column（5 μm, 250 mm×4.6 mm）, using a mobile phase composition of Phosphate buffer（Weigh potassium dihydrogen phosphate 16.33 g, 3 m L ethylamine, 900 m L water, with phosphoric acid solution to adjust the p H value to 2.5） and methanol（19∶1）; the determination wavelength was 225 nm, column temperature was 40 ℃ and the flow rate was 1.0 m L/min.Result： After the Study on methodology for determination, It Indicated that the specificity of method was good; and ezetimibe had a good linear range of 16.75-83.76 μg/m L with a mean recovery of 98.8 %（RSD=0.3 %）. Conclusion： The assay showed an accurate result, high precision and good durability, which can used as a method for determination of Fenoldopam in Fenoldopam mesylate injection.