natural products related Can I get hplc method for clevidipine butyrate?
Dear Praveen,
The following paper covers the requested method:
J Chromatogr Sci. 2015 Oct 21. pii: bmv148. [Epub ahead of print]
Structural Analysis and Quantitative Determination of Clevidipine Butyrate Impurities Using an Advanced RP-HPLC Method.
Zhou Y1, Zhou F2, Yan F1, Yang F1, Yao Y1, Zou Q3.
Author information
Abstract
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.
http://www.ncbi.nlm.nih.gov/pubmed/26489435
Hoping this will be helpful,
Rafik
Dear Praveen,
The following paper covers the requested method:
J Chromatogr Sci. 2015 Oct 21. pii: bmv148. [Epub ahead of print]
Structural Analysis and Quantitative Determination of Clevidipine Butyrate Impurities Using an Advanced RP-HPLC Method.
Zhou Y1, Zhou F2, Yan F1, Yang F1, Yao Y1, Zou Q3.
Author information
Abstract
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.
http://www.ncbi.nlm.nih.gov/pubmed/26489435
Hoping this will be helpful,
Rafik
Dear Tareq and dear Praveen,
Since me and Tareq have suggested the same article I was expecting that my answer will be up-voted, however, unfortunately, for some reason or mistakenly my answer was down-voted.
Rafik
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