A validated chiral HPLC method for the enantiomeric separation of tolterodine tartarate
Y Ravindra Kumar1, G Ramulu, V V Vevakanand
1Dr. Reddy's Laboratories Ltd., Bulk Actives Unit-III, IDA-Bollaram, Hyderabad 502325, AP, India.
Abstract:
An isocratic chiral HPLC method was developed for the separation of tolterodine tartarate enantiomers. The mobile phase consists of n-hexane and isopropyl alcohol in the ratio of 980:20 (v/v) with 1 ml diethylamine and 0.6 ml trifluoroacetic acid. Chiralcel OD-H (250 mm x 4.6mm) column was used at constant room temperature. Flow rate was kept at 0.5 ml/min. This method is capable of detecting the S-isomer up to 0.1 microg/ml. The method was validated in terms of linearity, precision, limit of detection (LOD) and limit of quantification (LOQ).
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