HPLC ANALYSIS OF HALOPERIDOL AND ITS RELATED COMPOUND IN THE DRUG SUBSTANCE AND A TABLET DOSAGE FORM USING A NON-POROUS SILICA OCTADECYLSILANE COLUMN

Abstract

A fast and sensitive reverse phase HPLC-UV method for the separation and quantitation of haloperidol and its related compound 4,4′-Bis[4-(p-chlorophenyl)-4-hydroxypiperidino] bu-tyrophenone} in both drug substance and tablet dosage form is reported. A non-porous silica (NPS) ODS-1 column was used as the stationary phase and the mobile phase consisted of 77:23 v/v 50 mM phosphate buffer with 0.2% triethylamine (TEA) pH 2.5/acetonitrile. The flow rate was 1.0 mL/min with detection at 220 nm. The method was successfully applied to the determination of haloperidol and its related compound in both drug substance and tablet dosage form. The detection limits were 1 ng/mL and 10 ng/mL for haloperidol and its related compound, respectively, based on a signal to noise ratio of 3 and a 10 μL injection. Linear calibration curves of 10–150 μg/mL and 0.2–15 μg/mL, for haloperidol and its related compound, respectively, showed coefficients of determination of 0.9993 (n=6). Precision calculated as % RSD and accuracy calculated as % error were within 0.087–1.52% and 0.22–1.41%, respectively, for haloperidol and 0.311–2.561% and 0.60–3.44%, respectively, for the related compound.