High-performance liquid chromatographic method with diode array detection for quantification of haloperidol levels in schizophrenic patients during routine clinical practice

Abstract

Rationale: Till date, very few HPLC methods are available with short run time for monitoring of haloperidol, facilitating large number of sample analysis within short time frame. Objective: A selective and sensitive reverse phase high-performance liquid chromatographic assay has been developed for monitoring of Haloperidol levels. Methodology: Chromatogram separation of Haloperidol and Loratidine (Internal Standard) was achieved using C18 column as stationary phase. Mobile phase consists of Acetonitrile and Water (50:50), pH-2.5 with 0.1% Acetic Acid and 0.05 M KHPO4 at a flow rate of 1.6 mL min-1. Detection was carried out at 240 nm using UV-PDA detector. Retention time for Haloperidol and Internal Standard was found to be 2:13 and 3:16 minutes respectively. The method has been validated for linearity, specificity, robustness, stability, accuracy and precision. Results: Linearity for Haloperidol was in the range of 03-200 ng mL-1. The total run time of analysis was 5 minutes and the lower limits of detection and quantification were 1.0 and 3.0 ng mL-1 respectively. In present study, most of the enrolled patients were clinically stable on Haloperidol (as evident from various rating scales applied during the study period) at therapeutic range of 5-19 ng mL-1 [13.04 ± 4.03] Discussion: This validated high-performance liquid chromatographic method using a simple mobile phase has been successfully applied for clinical monitoring of Haloperidol in psychiatric patients. The method is economic and its time sparing ability using simple RP-HPLC speaks its utility in clinical and toxicological management over other analytical methods. © 2011 Jain T, et al.