Quantitation of olanzapine in tablets by HPLC, CZE, derivative spectrometry and linear voltammetry.
Four analytical methods have been developed for the quality control of pharmaceutical formulations containing the novel antipsychotic drug, olanzapine: high performance liquid chromatography (HPLC), capillary zone electrophoresis (CZE), derivative spectrometry and linear voltammetry. All methods require only a simple extraction procedure of olanzapine from the tablets before analysis. HPLC with ultraviolet detection at 260 nm is carried out with a C8 column and a mobile phase constituted of acetonitrile and aqueous tetramethylammonium perchlorate. CZE is performed in an uncoated capillary with phosphate buffer, pH 3.0, as the background electrolyte, with UV detection at 214 nm. Spectrophotometry uses the derivative of the spectrum at 298 nm. In linear voltammetric method (LSV) the current intensity of the oxidation wave at +495 mV is measured. All methods gave similar results in terms of precision and accuracy. For HPLC and CZE, repeatability and intermediate precision, expressed by the RSD was better than 1.8%. The accuracy, resulting from recovery experiments, was between 99.9 and 101.1%. Spectrometry and voltammetry gave slightly higher RSD values (up to 2.9%) and a larger variation of the accuracy (the recovery was between 97.8 and 102.6%). However, the requirements for quantitative analysis are fulfilled for all methods.
Raggi
M A
MA
Department of Pharmaceutical Sciences, University of Bologna, Italy. raggima@alma.unibo.it
Casamenti
G
G
Mandrioli
R
R
Izzo
G
G
Kenndler
E
E
D014150:Antipsychotic Agents / Q000032:analysis*; D001569:Benzodiazepines; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D019075:Electrophoresis, Capillary / Q000379:methods*; D000077152:Olanzapine; D010890:Pirenzepine / Q000031:analogs & derivatives* / Q000032:analysis; D015203:Reproducibility of Results; D013053:Spectrophotometry / Q000379:methods*; D013607:Tablets
D014150:Antipsychotic Agents; D013607:Tablets; D001569:Benzodiazepines; D010890:Pirenzepine; D000077152:Olanzapine