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Stability evaluation of tramadol enantiomers using a chiral stability‐indicating capillary electrophoresis method and its application to pharmaceutical analysis
Author(s) -
Mohammadi Ali,
Nojavan Saeed,
Rouini Mohammadreza,
Fakhari Ali Reza
Publication year - 2011
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.201100021
Subject(s) - enantiomer , chromatography , chemistry , capillary electrophoresis , detection limit , maltodextrin , enantiomeric excess , resolution (logic) , enantioselective synthesis , organic chemistry , spray drying , catalysis , artificial intelligence , computer science
In this study, a chiral stability‐indicating CE assay was developed for the stability evaluation of tramadol (TR) enantiomers in commercial tablets using maltodextrin as chiral selector. To investigate the stability‐indicating power of the analytical method as well as stability evaluation of TR enantiomers, active pharmaceutical ingredient and TR tablets were subjected to photolysis, heat, oxidation and hydrolysis to conduct stress testing. Best separation for the TR enantiomers was achieved on an uncoated fused‐silica capillary at 20°C using borate buffer (50 mM, pH 10.2) containing 10% m/v maltodextrin. All determinations were performed by a UV detector at 214 nm. A constant voltage of 20 kV was applied to obtain the separation. The range of quantitation for both enantiomers was 5–100 μg/mL ( R >0.996). Intra‐ and inter‐day RSD ( n =6) were less than 10%. The percent relevant errors were obtained to be less than 4.0 for both enantiomers. The limits of quantitation and detection for both enantiomers were 5 and 1.5 μg/mL, respectively. Degradation products resulting from the stress studies were the same for both enantiomers and did not interfere with the detection of the enantiomers.