Abstract
HCl Two stability-indicating methods were developed for the determination of atomoxetine hydrochloride (ATM) and validated in the presence of its degradation products. Method I is based on (UPLC) separation of ATM from its alkaline, oxidative, and acidic degradation products on Zorbax SB C18 column using acetonitrile -aqueous 0.01M triethylamine, pH 4.2 (50:50, v/v) mobile phase. Photodiode array detection at 205 nm was used for quantitation of ATM over the range of 0.1-35 µg/ml. The run time was 2.5 min within which ATM and its degradation products were well separated. The method was also applied to the determination of ATM in spiked human plasma over the range of 0.1-4 µg/ml. Moreover, the produced acidic degradation products were isolated, and structural elucidation of the degradates was done by LC/MS spectrometry studies. A proposal of the acid hydrolysis pathway was presented. Method IIA describes direct measurement of the intrinsic fluorescence intensity of both ATM and its known acid degradates using sodium dodecyl sulfate as fluorescence enhancer in aqueous solutions. This method was extended to (Method IIB) to apply first derivative synchronous fluorescence spectroscopy for the simultaneous analysis of ATM and its acidic depredates. The proposed methods were successfully applied to quantify ATM in commercial capsules and the results were in good agreement with those obtained using a reference method.
Highlights
Atomoxetine HCl (ATM), (R) n-methyl-3-(2-methylphenoxy)-3phenyl propylamine hydrochloride, has a formula of C17H21NO
The proposed methods were successfully applied to quantify ATM in commercial capsules and the results were in good agreement with those obtained using a reference method
Linearity and construction of calibration curve: After following the procedures mentioned in method IIA, the first derivative fluorescence spectra of ATM and its acid-induced degradation products was derived from the normal synchronous spectra using FL Solutions software
Summary
Atomoxetine HCl (ATM), (R) n-methyl-3-(2-methylphenoxy)-3phenyl propylamine hydrochloride, has a formula of C17H21NO. It is a norepinephrine selective reuptake inhibitor that is used in the treatment of ADHD (attention-deficit hyperactivity disorder). It is thought to improve ADHD symptoms by blocking norepinephrine reuptake and thereby increasing norepinephrine levels in the prefrontal cortex. ATM has several advantages over the amphetamines, including a lower abuse/addiction potential and a longer plasma half-life that allows for once daily dosing. ATM increases peripheral as well as central norepinephrine levels, and increases heart rate and blood pressure [1,2]
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