Pharmaceutica Analytica Acta

Abstract

Stability Indicating Spectrophotometric and Chemometric Methods for Determination of Nifuroxazide in Presence of Its Alkaline Degradation Products

Maha A. Hegazy, Waleed A. Hassanain and Laila E. Abdel-Fattah

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.