Abstract
Simple, accurate, sensitive and precise Spectrophotometric and Chemometric methods were developed and validated for determination of Nifuroxazide (Nx) in presence of its alkaline degradation products. Two spectrophotometric methods were investigated, the first one is a second derivative spectrophotometric ( 2 D) determination of Nx in presence of its alkaline degradation products by measuring the peak amplitude at λ=278 nm which corresponds to (zero crossing) of its degradates. While, the second one is a second derivative ratio spectra ( 2 DD) which could successfully determine without any interference from its degradates at λ=290.8, The percentage recoveries of pure was found to be 99.97±1.505 & 99.83±1.401 for ( 2 D) & ( 2 DD) respectively. Chemometric-assisted spectrophotometric methods were also applied as classical least squares (CLS), principal component regression (PCR) and partial least squares (PLS), the percentage recoveries for Nx were 99.49 ±2.60 , 98.914 ±1.68 and 99.08 ±1.38 for CLS, PCR and PLS, respectively. The developed chemometric models have the advantage that they are not only determine the drug in presence of its degradates but also quantify the degradates in the mixtures. All the developed methods were successfully applied for the determination of Nx in its bulk powder and dosage form and the validity of the proposed methods was further assessed by applying the standard addition technique. The developed methods were statistically compared with each other and with a reported method and no significant difference were observed regarding both accuracy and precision, all the developed methods have been validated according to ICH guidelines.
Highlights
Nifuroxazide (Nx) is a broad spectrum intestinal anti-infectious agent with a strictly local action suitable for diarrhea
Different methods have been reported for the determination of Nx in biological fluids either in pharmaceutical dosage forms, in combination with other drugs or in the presence of its metabolites; these methods include spectrophotometry [4,5] liquid chromatography-UV photodiode array detection [6], high performance liquid chromatography (HPLC) [7,8,9], voltammetry [10,11,12,13] differential pulse polarography [14] and colorimetry [7]
The scientific novelty of the present work is that the methods used are simple, rapid, selective, less expensive and less time consuming compared with other published LC, TLC and HPLC methods, these methods could determine the intact drug without any interference from its degradation products
Summary
Nifuroxazide (Nx) is a broad spectrum intestinal anti-infectious agent with a strictly local action suitable for diarrhea. It is chemically designated as 4-Hydroxybenzoic acid[(5-nitro-2-(furanyl)methylene] hydrazide [1], Figure 1. The scientific novelty of the present work is that the methods used are simple, rapid, selective, less expensive and less time consuming compared with other published LC, TLC and HPLC methods, these methods could determine the intact drug without any interference from its degradation products. The aim of this work was to develop simple, sensitive and validated spectrophotometric and chemometric methods for the determination of Nx in the presence of its degradation product in powdered forms, laboratory prepared mixtures and in pharmaceutical formulation. The applied methods are second derivative (2D) and second derivative ratio (2DD), and chemometric methods as classical least squares (CLS), principal component regression (PCR) and partial least squares (PLS)
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