Structural Analysis and Quantitative Determination of Clevidipine Butyrate Impurities Using an Advanced RP-HPLC Method.
Eleven potential impurities, including process-related compounds and degradation products, have been analyzed by comprehensive studies on the manufacturing process of clevidipine butyrate. Possible formation mechanisms could also be devised. MS and NMR techniques have been used for the structural characterization of three previously unreported impurities (Imp-3, Imp-5 and Imp-11). To separate and quantify the potential impurities in a simultaneous fashion, an efficient and advanced RP-HPLC method has been developed. In doing so, four major degradation products (Imp-2, Imp-4, Imp-8 and Imp-10) can be observed under varying stress conditions. This analytical method has been validated according to ICH guidelines with respect to specificity, accuracy, linearity, robustness and stability. The method described has been demonstrated to be applicable in routine quality control processes and stability evaluation studies of clevidipine butyrate.
The Third Affiliated Hospital of Guiyang Medical University, Duyun 558000, China.
Yuxia
Y
Zhou
College of Food Science and Light Industry, Nanjing Tech University, Nanjing 210009, China.
Fan
F
Zhou
The Third Affiliated Hospital of Guiyang Medical University, Duyun 558000, China.
Fei
F
Yan
The Third Affiliated Hospital of Guiyang Medical University, Duyun 558000, China.
Feng
F
Yang
The Third Affiliated Hospital of Guiyang Medical University, Duyun 558000, China.
Yuxian
Y
Yao
School of Pharmaceutical Sciences, Nanjing Tech University, Nanjing 210009, China qiaogenzou@hotmail.com.
Qiaogen
Q
Zou
D002087:Butyrates / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004340:Drug Contamination / Q000517:prevention & control; D004345:Drug Industry; D004355:Drug Stability; D006801:Humans; D011725:Pyridines / Q000032:analysis*; D011786:Quality Control; D015203:Reproducibility of Results
D002087:Butyrates; D011725:Pyridines; C118563:clevidipine