QUALITY CONTROL OF PHARMACEUTICAL FORMULATIONS OF NEUROLEPTIC DRUGS BY CAPILLARY ZONE ELECTROPHORESIS

Abstract

Classical (haloperidol and chlorpromazine) and atypical neuroleptics (olanzapine, clozapine, loxapine, and risperidone) were quantified in pharmaceutical formulations (tablets, capsules, and oral solutions) by capillary zone electrophoresis. The simple sample pretreatment consists of a one-step extraction, filtration, and dilution. The electrophoretic conditions were as follows: uncoated fused-silica capillary (28.3 cm total length, 22.0 cm effective length, 50 μm I.D.), phosphate buffer (pH 2.5, ionic strength 35 mmol/L). The separation voltage (15 kV) results in a current lower than 50 μA. UV detection was performed at 214 nm. Calibration curves were linear in the 5–50 μg/mL range for all tested drugs (r better than 0.999). The repeatability (or intra-day precision), expressed by the relative standard deviation, was better than 2% (6 measurements). The accuracy, resulting from recovery studies, was between 98 and 105 %. The amount of drug found agreed with the declared contents within the limits specified by U.S.P. (1995).

ACKNOWLEDGMENTS

V. Pucci's permanent address: University of Bologna. Financial support by the “Hochschuljubiläumsstiftung der Stadt Wien” (project number 210/97) is acknowledged. We also thank Eli Lilly, Novartis, Rhone-Poulenc Rorer, Lederle Laboratories, Janssen-Cilag, Lusofarmaco, and Sigma for the donations of the respective drugs.