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Spectrofluorimetric and Spectrophotometric Stability- Iwndicating Methods for the Analysis of Veralipride in Presence of Its Degradants and in Spiked Human Plasma

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Chinese Journal of Chemistry 2012年第1期30卷 183-189页

作者： Salama,Nahla Nour El Din Ahmed salem,maissa yacoub Abd El Halim,Lobna Mohammed Abdel Fattah,Laila EI-Sayed National Organization for Drug Control and Research(NODCAR) 6 Abu Hazem StreetPyramids AveP.O.Box 29GizaEgypt Analytical Chemistry Department Faculty of PharmacyCairo UniversityCairoEgypt Analytical Chemistry Department Faculty of PharmacyMisr University for Science and Technology6th of OctoberEgypt

Spectrofluorimetric and spectrophotometric stability-indicating methods were developed and validated for analysis of veralipride （Ver） in presence of its hydrolytic and oxidative degradants. The spectrofluorimetric method was based on direct measurement of the intrinsic fluorescence of Ver at 366 nm after excitation at 299 nm using sodium lauryl sulfate （SLS） as micelle enhancer. The fluorescence intensity plot was linear over the concentration range 1.0-10.0 ***-1. The high sensitivity of the method allowed its successful application to the analysis of Ver in spiked human plasma. Two other methods were developed. They are based on the oxidative coupling reac- tion of Vet with 3-methyl benzothiazolin-2-one hydrazone （MBTH） hydrochloride in presence of ceric ammonium sulphate in an acidic medium. The first method depends on spectrophotometric measurement of the stable green colored oxidative coupling product at 660 nm. The different experimental parameters affecting the reaction were optimized. Linearity range is 10.0--100.0 ~tgomL-1. The second method depends on a fluorescence quenching effect of Vet on the fluorescence of Ce3＋. The difference in fluorescence intensity was measured at 380 nm after excitation at 300 nm. This method is applicable over the concentration ranges 0.25-2.50 pg-mL-1. The methods were validated according to the ICH guidelines. They were successfully applied for the analysis of Ver in drug substance, drug product and in laboratory prepared mixtures containing different percentages of hydrolytic and oxidative degradants.

关键词： veralipride micelle-enhanced fluorescence MBTH validation stability fluorescence quenching Ce3+

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