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目的:建立测定福辛普利钠片中主药及有关物质A含量的HPLC法。方法:采用外标法,选择Agilent C18柱(150 mm×4.6 mm,5μm)为固定相,甲醇-0.2%磷酸溶液(体积比80∶20)为流动相,流速1.0 mL.min-1,检测波长215 nm。结果:福辛普利钠和有关物质A质量浓度分别在4.8～193.4 mg.L-1和0.2～10.3 mg.L-1范围内,其色谱峰面积与质量浓度的线性关系良好。福辛普利钠含量测定的加样回收率平均值为101.26%。测得3批样品中的福辛普利钠含量分别为标示量的95.8%、96.4%和96.0%,有关物质A含量分别为标示量的0.9%、0.7%和0.8%。结论:该法灵敏度高、专属性强、简便可靠,可用于福辛普利钠片中主药及有关物质A的含量测定。
Objective: To establish an HPLC method for the determination of the main drug and related substance A in fosinopril sodium tablets. Methods: The external standard method was used. The mobile phase was Agilent C18 column (150 mm × 4.6 mm, 5 μm) with methanol-0.2% phosphoric acid solution (volume ratio 80:20) Wavelength 215 nm. Results: Fosinopril sodium and related substance A concentration ranged from 4.8 to 193.4 mg.L-1 and 0.2 to 10.3 mg.L-1, respectively. The linear relationship between peak area and mass concentration was good. The average recoveries of fosinopril sodium were 101.26%. The contents of fosinopril sodium in the three batches of samples were 95.8%, 96.4% and 96.0% of the labeled amount respectively, and the contents of related substances A were 0.9%, 0.7% and 0.8% respectively of the labeled amounts. Conclusion: The method is sensitive, specific, simple and reliable, and can be used for the determination of the main drug and related substance A in fosinopril sodium tablets.