Comparison of three analytical methods for quality control of clozapine tablets.
Three different analytical methods for the quality control of clozapine in commercial formulations were developed and compared: a liquid chromatographic (LC) method with UV detection, a capillary zone electrophoretic (CZE) method, and a linear scan voltammetric (LSV) method. The isocratic LC procedure used a C18 reversed-phase column; the CZE method used an uncoated fused-silica capillary and phosphate buffer containing polyvinylpyrrolidone as the background electrolyte; the LSV method analyzed clozapine solutions with acidic phosphate buffer as the supporting electrolyte. The 3 methods gave similar and satisfactory results, in terms of precision and accuracy. Repeatability and intermediate precision were good (RSD% < 2.2) and accuracy, resulting from recovery studies, was between 98 and 102%. The rapidity of analysis was high for all 3 methods, especially for the LSV.
Raggi
M A
MA
University of Bologna, Department of Pharmaceutical Sciences, Italy.
Pucci
V
V
Bugamelli
F
F
Volterra
V
V
D014150:Antipsychotic Agents / Q000032:analysis*; D002853:Chromatography, Liquid; D003024:Clozapine / Q000032:analysis*; D004563:Electrochemistry; D019075:Electrophoresis, Capillary; D007202:Indicators and Reagents; D011786:Quality Control; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D014150:Antipsychotic Agents; D007202:Indicators and Reagents; D012996:Solutions; D013607:Tablets; D003024:Clozapine