An enantiospecific HPLC method for the determination of (S)-enantiomer impurities in (R)-tolterodine tartarate.

摘要: A high-performance liquid chromatographic method was developed for the separation of enantiomers tolterodine tartarate. The proposed applied to determination (S)-isomer in (R)-tolterodine tartarate, and satisfactory results were obtained. tartarate separated on a Chiralpak AD-H (250 mm x 4.6 mm) column containing amylose tris-(3,5-dimethylphenyl-carbamate) at room temperature. mobile phase consisted n-hexane isopropyl alcohol ratio 85:15 (v/v) with 0.075% triethylamine (TEA) 0.05% trifluoroacetic acid (TFA) as additive. flow rate kept 0.5 ml/min, UV detection wavelength set 283 nm. calibration curves (S)-enantiomer concentration range from 0.05 microg/ml 1 linear. relative standard deviations within-day between-day less than 2% (n = 3). limit (LOD) 0.75 ng (S/N 3) quantification (LOQ) (RSD < 4.1%, n recoveries 98.2-104.8%. demonstrated that HPLC reliable, simple technique applicable purity (R)-