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用于测定原料药和药物制剂中普瑞巴林的分光光度法和荧光分光光度法。

Spectrophotometric and spectrofluorimetric methods for the determination of pregabalin in bulk and pharmaceutical preparation.

作者信息

Onal Armağan, Sagirli Olcay

机构信息

Istanbul University, Faculty of Pharmacy, Department of Analytical Chemistry, 34116 Beyazit, Istanbul, Turkey.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2009 Feb;72(1):68-71. doi: 10.1016/j.saa.2008.08.009. Epub 2008 Aug 28.

DOI:10.1016/j.saa.2008.08.009
PMID:18922737
Abstract

Two new, sensitive and selective spectrofluorimetric and spectrophotometric methods have been developed for the determination of the gamma-amino-n-butyric acid derivative pregabalin (PGB) in bulk drug and capsule. Pregabalin, as a primary amine compound, reacts with 7-chloro-4-nitrobenzofurazon (NBD-Cl) which is a highly sensitive fluorogenic and chromogenic reagent used in many investigations. According to this fact, spectrophotometric and spectrofluorimetric methods for the determination of pregabalin in capsules were developed for the first time. The relation between the absorbance at 460 nm and the concentration is rectilinear over the range 0.5-7.0 microg mL(-1). The reaction product was also measured spectrofluorimetrically at 558 nm after excitation at 460 nm. The fluorescence intensity was directly proportional to the concentration over the range 40-400 ng mL(-1). The method was applied successfully to the determination of this drug in pharmaceutical dosage form. The mean recovery for the commercial capsules was 99.93% and 99.96% for spectrophotometric and spectrofluorimetric study, respectively. The suggested procedures could be used for the determination of PGB in pure and capsules being sensitive, simple and selective.

摘要

已开发出两种新的、灵敏且具选择性的荧光分光光度法和分光光度法,用于测定原料药及胶囊中的γ-氨基丁酸衍生物普瑞巴林(PGB)。普瑞巴林作为一种伯胺化合物,与7-氯-4-硝基苯并呋咱(NBD-Cl)发生反应,NBD-Cl是一种在许多研究中使用的高灵敏荧光和显色试剂。基于这一事实,首次开发出用于测定胶囊中普瑞巴林的分光光度法和荧光分光光度法。在0.5 - 7.0 μg mL⁻¹范围内,460 nm处的吸光度与浓度呈线性关系。反应产物在460 nm激发后,也于558 nm处进行荧光分光光度测定。在40 - 400 ng mL⁻¹范围内,荧光强度与浓度成正比。该方法成功应用于药物剂型中该药物的测定。分光光度法和荧光分光光度法对市售胶囊的平均回收率分别为99.93%和99.96%。所建议的方法可用于测定纯品及胶囊中的PGB,具有灵敏、简便且具选择性的特点。

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