Abstrakt

Development and validation of a capillary electrophoresis method for determining zolmitriptan enantiomers

Muzaffar Khan, K.V.S.R.Krishna Reddy, P.K.Dubey, B.Mallikarjuna Rao

A cyclodextrin mediated capillary electrophoresis (CE) methods for determining the enantiomeric purity of Zolmitriptan in the presence of its potential process related impurities was developed with a systematic method development approach. The separation between Zolmitriptan enantiomers and potential impurities could be obtained in two background electrolyte (BGE) systems containing hydroxypropyl beta-cyclodextrin (HP-â-CD) and sulfobutyl ether-beta-cyclodextrin (SB-â-CD) respectively. The CE method containing SB-â-CD in the BGE system was validated as it provided higher efficiency and resolution between the enantiomers. The separation was carried out at 25°C in a 72 cm x 50 µm id bare fused silica “Extended light path” capillary with an applied voltage of 30kV, polarity set to negative. The background electrolyte (BGE) consisted of citrate buffer (pH 4.6, 50 mM) containing 20 mM sulfobutyl ether-beta-cyclodextrin (SB-â-CD) and the peaks were detected at 225 nm. The method was found to be specific, accurate and precise. The CE method can be conveniently applied for the analysis of bulk and formulation samples of Zolmitriptan.