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分光光度法测定纯加替沙星及药物制剂中的加替沙星。

Spectrophotometric determination of gatifloxacin in pure form and in pharmaceutical formulation.

作者信息

Amin Alaa S, El-Fetouh Gouda Ayman Abou, El-Sheikh Ragaa, Zahran Faten

机构信息

Chemistry Department, Faculty of Science, Benha University, Benha, Egypt.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2007 Aug;67(5):1306-12. doi: 10.1016/j.saa.2006.09.041. Epub 2006 Oct 14.

Abstract

Simple, rapid, and extractive spectrophotometric methods were developed for the determination of gatifloxacin (GT) in bulk and pharmaceutical dosage form. These methods are based on the formation of yellow ion-pair complexes between the basic nitrogen of the drug and three sulphonphthalein acid dyes, namely; bromocresol green (BCG), bromocresol purple (BCP), bromophenol blue (BPB) and bromothymol blue (BTB) in phthalate buffer pH 3.0, 3.4 and 3.2, using BCG, BCP and (BPB or BTB), respectively. The formed complexes were extracted with chloroform and measured at 415, 417, 412 and 414 nm for BCG, BPB, BCP and BTB, respectively. The analytical parameters and their effects on the reported systems are investigated. The reactions were extremely rapid at room temperature and the absorbance values remains unchanged at 48 h for all reactions. Beer's law was obeyed in the ranges 2.0-20, 2.0-14 and 2.0-16 microg mL(-1) for BCG, BCP and (BPB or BTB), respectively. The composition of the ion pairs was found 1:1 by Job's method. Beer's law validation, accuracy, precision, limits of detection, limits of quantification. The proposed methods have been applied successfully for the analysis of the drug bulk form and its dosage form. The results were in good agreement with those obtained by the official and reported methods.

摘要

开发了简单、快速且萃取分光光度法用于测定原料药和药物剂型中的加替沙星(GT)。这些方法基于在邻苯二甲酸盐缓冲液pH 3.0、3.4和3.2中,药物的碱性氮与三种磺酞酸染料(即溴甲酚绿(BCG)、溴甲酚紫(BCP)、溴酚蓝(BPB)和溴百里酚蓝(BTB))形成黄色离子对络合物,分别使用BCG、BCP和(BPB或BTB)。形成的络合物用氯仿萃取,分别在415、417、412和414 nm处测定BCG、BPB、BCP和BTB。研究了分析参数及其对所报道体系的影响。反应在室温下极快,所有反应在48小时内吸光度值保持不变。BCG、BCP和(BPB或BTB)分别在2.0 - 20、2.0 - 14和2.0 - 16 μg mL⁻¹范围内符合比尔定律。通过乔布法发现离子对的组成是1:1。进行了比尔定律验证、准确度、精密度、检测限、定量限。所提出的方法已成功应用于药物原料药及其剂型的分析。结果与官方和报道方法获得的结果良好一致。

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