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

作　　者：Nouruddin W.Ali Samah Sayed Abbas Hala El-Sayed Zaazaa Maha Mohamed Abdelrahman Mohamed Abdelkawy 

机构地区：[1]Analytical Chemistry Department,Faculty of Pharmacy,Beni-Suef University,Hussin El-Shafey Street,Beni-Suef City,Egypt [2]Analytical Chemistry Department,Faculty of Pharmacy,Cairo University,Kasr El-Aini Street,11562,Cairo,Egypt

出　　处：《Journal of Pharmaceutical Analysis》2012年第2期105-116,共12页药物分析学报（英文版）

摘　　要：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 260-360 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 60F 254,using chloroform-methanol-ammonia solution-glacial 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.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 260-360 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 60F 254,using chloroform-methanol-ammonia solution-glacial 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.

关 键 词：NITAZOXANIDE DEGRADATION Derivative spectrophotometry CHEMOMETRICS TLC-DENSITOMETRY Stability-indicating methods 

分 类 号：R927.2[医药卫生—药学]