Issue 10, 2001

Optimisation and validation of a capillary electrophoresis method for the simultaneous determination of diazepam and otilonium bromide

Abstract

A simultaneous assay of diazepam and otilonium bromide in coated tablets by capillary zone electrophoresis (CZE) was developed. The influence of various parameters (voltage, temperature, buffer concentration and pH, ethanol percentage) on analysis time and on the theoretical plates of the two peaks was investigated by means of experimental design. A response surface study was carried out by means of a 27-run D-optimal matrix. The best background electrolyte was found to be 0.13 M, pH 2.9 Britton–Robinson buffer, containing 10% v/v ethanol. Other optimised parameters were voltage (30 kV) and temperature (30 °C). The UV detector for quantitation of otilonium bromide and diazepam was set at 280 nm and 230 nm, respectively. Procaine hydrochloride was used as internal standard and run time was less than five minutes. Validation was performed, for drug substance and drug product, according to ICH3 guidelines. For drug product the recovery for otilonium bromide and diazepam ranged from 98.3% to 101.2% and from 97.1% to 99.0%, respectively; the RSD values found for otilonium bromide and diazepam ranged from 2.4% to 3.0% and from 1.1% to 4.5%, respectively.

Article information

Article type
Paper
Submitted
05 Apr 2001
Accepted
23 Jul 2001
First published
17 Sep 2001

Analyst, 2001,126, 1700-1706

Optimisation and validation of a capillary electrophoresis method for the simultaneous determination of diazepam and otilonium bromide

S. Furlanetto, S. Orlandini, G. Massolini, M. T. Faucci, E. La Porta and S. Pinzauti, Analyst, 2001, 126, 1700 DOI: 10.1039/B103091B

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