摘要
目的建立测定普肾片中卡托普利含量的高效液相色谱法。方法采用C18色谱柱(250 mm×4.6 mm,5μm),0.01 mol/L磷酸二氢钠-甲醇-乙腈(75∶25∶5,磷酸调节pH至2.7～2.8)为流动相,流速为1.0 mL/min,检测波长为215 nm,柱温为40℃。结果卡托普利质量浓度在10.21～81.71μg/mL的范围内与峰面积呈良好线性关系,r=0.999 9,平均回收率为99.93%,RSD为1.25%(n=9)。结论该方法简便、准确,可作为该制剂的质量控制方法。
Objective To establish a HPLC method for the determination of the captopril content in Pushen Tablets. Methods The C18 column（250 mm×4.6 mm,5 μm） was adopted with 0.01 mol/L sodium dihydrogen phosphate-methanol-acetonitrile （75：25：5, adjusting pH to 2.7-2.8 with phosphoric acid） as the mobile phase. The flow rate was 1.0 mL/min,the detection wavelength was 215 nm and the column temperature was at 40℃. Results The linear range of captopril was obtained between 10.21- 81.71μg/mL, r = 0. 999 9,the average recovery rate was 99. 93%, RSD 1.25% （n =9）. Conclusion The established method is simple,accurate,and can be used for the quality control of this preparation.
出处
《中国药业》
CAS
2013年第2期20-21,共2页
China Pharmaceuticals
