Evaluation of Uncertainty for the Determination of Clozapine Tablets by HPLC

OBJECTIVE To evaluate the measurement uncertainty for the determination of clozapine tablets by HPLC. METHODS The mathematical model of determination by HPLC was established. The uncertainty sources had been analyzed. Each active component of uncertainty was calculated, and the expanded uncertainty was obtained. RESULTS The expanded uncertainty for the HPLC determination of clozapine was 0.9%, and the result of determination was(100.2±0.9)%, k=2. CONCLUSION The main sources of uncertainty are analyzed, which provide the reliable theoretical basis for effectively controlling of this method.