Validated stability indicating methods for determination of nitazoxanide in presence of its degradation products

• Main Authors: Nouruddin W. Ali, Samah Sayed Abbas, Hala El-Sayed Zaazaa, Maha Mohamed Abdelrahman, Mohamed Abdelkawy
• Format: Article
• Language: English
• Published: Elsevier 2012-04-01
• Series: Journal of Pharmaceutical Analysis
• Online Access: http://www.sciencedirect.com/science/article/pii/S2095177911000669

Three sensitive, selective and reproducible stability-indicating methods are presented for determination of nitazoxanide (NTZ), a new anti-protozoal drug, in presence of its degradation products. Method A utilizes the first derivative of ratio spectra spectrophotometry by measurement of the amplitude at 364.4 nm using one of the degradation products as a divisor. Method B is a chemometric-assisted spectrophotometry, where principal component regression (PCR) and partial least squares (PLS) were applied. These two approaches were successfully applied to quantify NTZ in presence of degradation products using the information included in the absorption spectra in the range 260â360 nm. Method C is based on the separation of NTZ from its degradation products followed by densitometric measurement of the bands at 254 nm. The separation was carried out on silica gel 60F254, using chloroformâmethanolâammonia solutionâglacial acetic acid (95:5:1:1 by volume, pH=5.80) as a developing system. These methods are suitable as stability-indicating methods for the determination of NTZ in presence of its degradation products either in bulk powder or in pharmaceutical formulations. Statistical analysis of the results has been carried out revealing high accuracy and good precision. Keywords: Nitazoxanide, Degradation, Derivative spectrophotometry, Chemometrics, TLC-densitometry, Stability-indicating methods