CHROMATOGRAPHIC METHODS FOR THE DETERMINATIONOF FLUPHENAZINE, NORTRIPTYLINE AND ITS IMPURITY AMITRIPTYLINE IN BULK AND PHARMACEUTICALFORMULATIONS

摘要

Two selective, reproducible methods were proposed for the simultaneous determination of Fluphenazine hydrochloride (Flu) and Nortriptyline hydrochloride (Nor) in the presence of its impurity Amitriptyline hydrochloride (Ami). The first method is TLC-densitometric on silica gel with ethyl acetate—methanol—concentrated ammonia 2:7:0.2 (v/v/v) as mobile phase. The linear range 0.5—20, 0.5-5 and 0.5-5 ug per spot for Nor, Ami and Flu respectively. The second method is HPLC on Genesis C_(18) column with 0.1 M ammonium acetate—acetonitrile 1:1 (v/v) as mobile phase and Ultraviolet detection at 254 nm. The LC method was linear over concentration ranges 100—500, 50—300 and 10—250 ug/mL for Nor, Ami and Flu respectively. The proposed methods were successfully applied for determination of these drugs in laboratory prepared mixtures, and in pharmaceutical dosage forms showing good accuracy and precision. The results obtained agreed statistically with those obtained by using the official methods.