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测定药物制剂和人血浆中某些氨基糖苷类抗生素的高灵敏度光谱荧光法。

Highly sensitive spectrofluorimetric method for determination of certain aminoglycosides in pharmaceutical formulations and human plasma.

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Minia University, Minia, Egypt.

出版信息

AAPS PharmSciTech. 2013 Jun;14(2):828-37. doi: 10.1208/s12249-013-9969-6. Epub 2013 Apr 26.

DOI:10.1208/s12249-013-9969-6
PMID:23620260
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3666013/
Abstract

A simple, reliable, highly sensitive and selective spectrofluorimetric method has been developed for determination of certain aminoglycosides namely amikacin sulfate, tobramycin, neomycin sulfate, gentamicin sulfate, kanamycin sulfate and streptomycin sulfate. The method is based on the formation of a charge transfer complexes between these drugs and safranin in buffer solution of pH 8. The formed complexes were quantitatively extracted with chloroform under the optimized experimental conditions. These complexes showed an excitation maxima at 519-524 nm and emission maxima at 545-570 nm. The calibration plots were constructed over the range of 4-60 pg mL(-1) for amikacin, 4-50 pg mL(-1) for gentamicin, neomycin and kanamycin, 4-40 pg mL(-1) for streptomycin and 5-50 pg mL(-1) for tobramycin. The proposed method was successfully applied to the analysis of the cited drugs in dosage forms. The proposed method was validated according to ICH and USP guidelines with respect to specificity, linearity, accuracy, precision and robustness. The high sensitivity of the proposed method allowed determination of amikacin and gentamicin in spiked and real human plasma.

摘要

已经开发出一种简单、可靠、高灵敏度和选择性的荧光光谱法,用于测定某些氨基糖苷类药物,如硫酸阿米卡星、硫酸妥布霉素、硫酸新霉素、硫酸庆大霉素、硫酸卡那霉素和硫酸链霉素。该方法基于这些药物与碱性藏红 T 在 pH 8 的缓冲溶液中形成电荷转移配合物。在优化的实验条件下,用氯仿定量萃取形成的配合物。这些配合物在 519-524nm 处有最大激发波长,在 545-570nm 处有最大发射波长。对于阿米卡星,校准曲线的范围为 4-60pg/mL;对于庆大霉素、新霉素和卡那霉素,校准曲线的范围为 4-50pg/mL;对于链霉素,校准曲线的范围为 4-40pg/mL;对于妥布霉素,校准曲线的范围为 5-50pg/mL。该方法成功地应用于制剂中这些药物的分析。该方法根据 ICH 和 USP 指南进行了专属性、线性、准确性、精密度和稳健性验证。该方法的高灵敏度允许在加标和真实人血浆中测定阿米卡星和庆大霉素。

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