卡托普利片含量测定及强制破坏后的降解产物分析  

Determination of Content and Degradation Compounds after Compulsory Destruction of Captopril Tablets

作　　者：王丽 傅安辰 Wang Li;Fu Anchen(Wuxi Institute for Drug Control,Jiangsu Wuxi 214028,China;Nanjing University of Chinese Medicine)

机构地区：[1]无锡市药品安全检验检测中心,江苏无锡214028 [2]南京中医药大学

出　　处：《中国药师》2020年第4期764-768,共5页China Pharmacist

摘　　要：目的:建立HPLC法测定卡托普利片含量并分离破坏后降解产物,采用液质联用技术对降解产物进行结构鉴定。方法:选取Lichrospher C18(250 mm×4.6 mm,5μm)色谱柱,流动相为甲醇-水-磷酸(40∶60∶0.05),流速为1.0 ml·min^-1,检测波长为215 nm,柱温为30℃,进样为20μl。对破坏后降解产物进行液相制备后,采用超高效液相色谱-四极杆飞行时间质谱(UHPLC-Q-TOF)对其进行结构确证。结果:在该色谱条件下制剂中其他成分不干扰测定,降解产物峰和卡托普利峰达到有效分离度。HPLC-QTOF MS可以对卡托普利片的主要降解产物进行结构确证。结论:建立了卡托普利片含量测定及有关物质检查的新方法,该法准确、可靠、重复性好,可用于控制卡托普利片的质量。Objective: To determine the contents of captopril tablets and the degradation compounds by HPLC and identify the degradation compounds using liquid chromatography-mass spectrometry. Methods: The detection was performed on a Lichrospher C18 column( 250 mm×4.6 mm,5 μm) with the mobile phase consisting of methanol,water and phosphoric acid( 40 ∶ 60 ∶ 0.05) at a flow rate of 1.0 ml·min^-1. The detection wavelength was set at 215 nm. The column temperature was 30 ℃ and the injection volume was 20μl. A UHPLC-QTOF MS method was used to identify the molecular structures of degradation compounds. Results: The other ingredients showed no any interference with the determination under the above conditions. The degradation compounds were completely separated from captopril. The main degradation compounds could be identified the structures by HPLC-QTOF MS. Conclusion: The new method,which is accurate,reliable and reproducible,can be used for determination the contents of captopril tablets and the degradation compounds and control the quality of captopril tablets.

关 键 词：卡托普利片 含量测定 降解产物 制备色谱 超高效液相色谱-四极杆飞行时间质谱 结构鉴定 

分 类 号：R917[医药卫生—药物分析学]