Premium
Development of a CZE method for the determination of mizolastine and its impurities in pharmaceutical preparations using response surface methodology
Author(s) -
Orlandini Serena,
Giannini Iacopo,
Gotti Roberto,
Pinzauti Sergio,
La Porta Enzo,
Furlanetto Sandra
Publication year - 2007
Publication title -
electrophoresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.666
H-Index - 158
eISSN - 1522-2683
pISSN - 0173-0835
DOI - 10.1002/elps.200600380
Subject(s) - triethanolamine , impurity , chromatography , response surface methodology , chemistry , phosphate buffered saline , analytical chemistry (journal) , organic chemistry
A fast and selective CZE method for the determination of mizolastine and related impurities is described. Response surface methodology was applied to study the influence of phosphate/triethanolamine (TEA) buffer concentration, heptakis(2,3,6‐tri‐ O ‐methyl)‐β‐CD (TMβCD) concentration, voltage and temperature. The optimum conditions were: 105 mM phosphate/TEA buffer (pH 3.0) containing 10 mM TMβCD, temperature 19°C and voltage 30 kV. Validation of the method was performed in drug substance and drug product. Robustness was evaluated using a Plackett–Burman design, including pH among the considered factors. Applying the optimal conditions, the nine peaks were baseline separated in about 10 min. The method was applied to the quality control of mizolastine in controlled‐release tablets.