A validated chiral HPLC method for the enantiomeric separation of tolterodine tartarate.
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).
Kumar, YR; Ramulu, G; Vevakanand, VV; Vaidyanathan, G; Srinivas, K; Kumar, MK; Mukkanti, K; Reddy, MS; Venkatraman, S; Suryanarayana, MV
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