HPLC测定非萘利酮片中非萘利酮的含量

Determination of Finerenone in Finerenone Tablets by HPLC

目的:建立非萘利酮片中非萘利酮的含量测定。方法:色谱柱为和谱科学AceChrom AQ C18 (250 × 4.6 mm, 5 μm),流动相为甲醇-0.03 mol/L的醋酸铵水溶液(45:55),流速为1.0 mL/min,检测波长为255 nm,柱温为35℃。结论:非萘利酮浓度在2~100 mL/L范围内与峰面积呈良好的线性关系,相关系数R2 = 0.9998。本实验采用高效液相色谱法对非萘利酮的含量进行了研究,为其质量控制提供了快速、有效的分析手段。该方法准确可靠,操作简便易行,可作为非萘利酮片的质量控制方法。Objective: To establish the determination of finerenone in finerenone tablets. Methods: The determination was performed on AceChrom AQ C18 column (250 × 4.6 mm, 5 μm) with mobile phase consisting of methanol-0.03 mol/L ammonium acetate aqueous solution (45:55) at the flow rate of 1.0 mL/min. The detection wavelength was 255 nm. The column temperature was 35˚C. Conclusion: The concentration of finalidone in the range of 2~100 mg/L has a good linear relationship with the peak area, and the correlation coefficient R2 = 0.9998. High-performance liquid chromatography (HPLC) was used to study the content of finalidone, which provided a rapid and effective method for quality control. The method is accurate, reliable, easy to operate, and can be used as a quality control method for finalidone tablets.