摘要
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 a HPLC method for determining the content of the main component and related substance A in fosinopril sodium tablets. The analysis was performed on a Agilent C18 column Methods： The external standard method was used. （150 mm ×4. 6 mm, 5μm）. The mobile phase was composed of methanol and 0. 2 % phosphoric acid with the volume ratio of 80： 20. The flow rate of mobile phase and the detection wavelength were 1.0 mL·min^-1 and 215 nm, respectively. Results： The chromatographic peak area and concentration of fosinopril sodium showed a good linear relationship at the range of 4. 8-193.4 mg·L^-1. The chromatographic peak area and concentration of related substance A showed a good linear relationship at the range of 0. 2-10.3 mg·L^-1. The average recovery of fosinopril sodium was 101.3 %. Three batches of samples contain fosinopril sodium of 95.8 %, 96.4 % and 96.0 % compared with labeled amount, respectively. In addition, the content of related substance A in the above samples was 0.9 %, 0.7 % and 0. 8 % of the labeled amount, respectively. Conclusion： The method is sensitive, specific, convenient and reliable. It can be used for the content determination of the main component and related substance A in the fosinopril sodium tablets.
出处
《药学进展》
CAS
2012年第2期79-82,共4页
Progress in Pharmaceutical Sciences
