Walash Mohamed I, Rizk Mohamed S, Eid Manal I, Fathy Mona E
University of Mansoura, Faculty of Pharmacy, Department of Analytical Chemistry, Mansoura 35516, Egypt.
J AOAC Int. 2007 Nov-Dec;90(6):1579-87.
A simple, rapid, and sensitive validated spectrophotometric method was developed for the determination of certain macrolide antibiotics namely, erythromycin (I), azithromycin dihydrate (II), clarithromycin (III), and roxithromycin (IV) in bulk powders, pharmaceutical formulations, and spiked biological fluids. The proposed method is based on the formation of a binary complex between each of the studied drugs and eosin Y in aqueous buffered medium. Under the optimum conditions, the binary complexes showed absorption maxima at 542-544 nm. The absorbance of the binary complexes obeyed Beer's law over the concentration range of 1-10 micro/g/mL for II, 2-20 microg/mL for I and IV, and 3-30 microg/mL for III. The mean percentage recoveries were 100.04 +/- 0.83, 99.98 +/- 0.80, 100.17 +/- 0.91, and 99.55 +/- 0.91, with minimum detectable molarities of 2 x 10(-7) for I and II, 4 x 10(-7) for III, and 3 x 10(-7) for IV. The different experimental parameters affecting the development and stability of the colors were studied and optimized. The proposed method was successfully applied to the analysis of the cited drugs in some pharmaceutical formulations. The results obtained were in good agreement with those obtained using the reference methods. The proposed method was further applied to spiked human urine and plasma. A proposal of the reaction pathway is suggested.
开发了一种简单、快速且灵敏的经过验证的分光光度法,用于测定散装粉末、药物制剂和加标生物流体中的某些大环内酯类抗生素,即红霉素(I)、二水阿奇霉素(II)、克拉霉素(III)和罗红霉素(IV)。所提出的方法基于在水性缓冲介质中,每种研究药物与曙红Y形成二元络合物。在最佳条件下,二元络合物在542 - 544 nm处有最大吸收。对于II,二元络合物的吸光度在1 - 10微克/毫升的浓度范围内符合比尔定律;对于I和IV,在2 - 20微克/毫升范围内;对于III,在3 - 30微克/毫升范围内。平均回收率分别为100.04±0.83、99.98±0.80、100.17±0.91和99.55±0.91,I和II的最低检测摩尔浓度为2×10⁻⁷,III为4×10⁻⁷,IV为3×10⁻⁷。研究并优化了影响颜色形成和稳定性的不同实验参数。所提出的方法成功应用于一些药物制剂中上述药物的分析。所得结果与使用参考方法获得的结果高度一致。所提出的方法进一步应用于加标人尿液和血浆。还提出了反应途径的建议。