Determination of Thioridazine Enantiomers in Human Serum by Sequential Achiral and Chiral High-Performance Liquid Chromatography

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Abstract
Quanitation of thioridazine (TRZ) enantiomers, (+)-TRZ and (−)-TRZ, in patient serums was performed by a sequential achiral and chiral HPLC method. The lower limit of quantitation was 50 ng/mL for each enantiomer, and the method was linear up to 1000 ng/mL. The within-run and between-run precision at 125 and 500 ng/mL of each enatiomer yielded coefficients of variation (CV) of less than 10% and less than 12%, respectively. Absolute recovery of 250 ng/mL racemic TRZ added to serum (n = 9) yielded mean recoveries of 77.2% and 77.8% for (+)-TRZ and (−)-TRZ, respectively. Absolute recovery of 1000 ng/mL racemic TRZ added to serum (n = 9) yielded mean recoveries of 74.0% and 74.7% for (+)-TRZ and (−-TRZ, respectively. Significantly different TRZ enantiomer concentrations were present in patient serums. The mean serum concentration was 110 ng/mL for (+)-TRZ (n = 18), and 317 ng/mL for (−)-TRZ (n = 21). The ratios of (−)-TRZ to (+)-TRZ ranged from 2.2 to 5.3, with a mean of 3.3. Variations in the concentration of TRZ enantiomers may contribute to the lack of correlation between serum TRZ values and therapeutic effect.

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