Stability Indicating Methods for Determination of Donepezil Hydrochloride According to ICH Guidelines
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概要
- 論文の詳細を見る
Stability indicating assays for determination of Donepezil Hydroehloride in presence of its oxidative degradate were developed and validated. The first three are spectrophotometric methods depending on using zero order (D^0), first order (D^1) and second order (D^2) spectra. The absorbance was measured at 315 nm for (D^0) while the amplitude was measured at 332.1nm for (D^1) and 340nm for (D^2) using deionized water as a solvent. Donepezil Hydrochloride (I) can be determined in the presence of up to 70% of its oxidative degradate (II) using (D^0), 80% using (D^1) and 90% using (D^2). The linearity range was found to be 8-56μg ml^<-1> for (D^0), (D^1) and (D^2). These methods were applied for the analysis of I in both powder and tablet form. Also, a spectrofluorimetric method depending on measuring the native fluorescence of I in deionized water using λ excitation 226nm and λ emission 391nm is suggested. The linearity range was found to be 0.32-3.20μg ml^<-1> using this method, I was determined in the presence of up to 90% of II. The proposed method was applied for the analysis of I in tablet form as well as in human plasma. The last method depends on using TLC separation of I from its oxidative degradate II and I was then determined spectrodensitometrically. The mobile phase was methanol: chloroform: 25% ammonia (16:64:0.1 by volume). The linearity range was found to be 2-15μg/spot. This method was applied to the analysis of I in both powder and tablet form using acetonitrile as a solvent.
- 公益社団法人日本薬学会の論文
- 2006-10-01
著者
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Abdel Fattah
Analytical Chemistry Department Faculty Of Pharmacy Cairo University
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Fayez Yasmin
Analytical Chemistry Department Faculty Of Pharmacy Cairo University
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ABBAS Samah
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University
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Abbas Samah
Analytical Chemistry Department Faculty Of Pharmacy Cairo University