alexa Validated Stability-Indicating UPLC and Derivative Synchronous Fluorescence Spectroscopy Methods for the Determination of Atomoxetine Hydrochloride in Pharmaceutical Preparation
ISSN : 2153-2435

Pharmaceutica Analytica Acta
Open Access

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Research Article

Validated Stability-Indicating UPLC and Derivative Synchronous Fluorescence Spectroscopy Methods for the Determination of Atomoxetine Hydrochloride in Pharmaceutical Preparation

Suzan Mahmoud Soliman1*, Heba MY El-Agizy1 and Abd El Aziz El Bayoumi2

1National Organization for Drug Control and Research (NODCAR), Giza, Cairo, Egypt

2Analytical Chemistry departments, Faculty of Pharmacy, Cairo University, Cairo, Egypt

*Corresponding Author:
Suzan Mahmoud Soliman
Pharmaceutical analytical chemistry Agousa 51 Wezaret El-Ziraa St.Cairo
P.O.Box 29, Egypt
Tel: 01001630499
E-mail: [email protected]

Received date: December 03, 2013; Accepted date: December 30, 2013; Published date: January 03, 2014

Citation: Soliman SM, El-Agizy HMY, El Bayoumi AEA (2014) Validated Stability- Indicating UPLC and Derivative Synchronous Fluorescence Spectroscopy Methods for the Determination of Atomoxetine Hydrochloride in Pharmaceutical Preparation. Pharm Anal Acta 5:278. doi: 10.4172/2153-2435.1000278

Copyright: © 2014 Soliman SM, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

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.

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