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使用折光指数检测器的新型环保高效液相色谱法分析药物制剂和大鼠血浆中的三种兽用抗生素

Novel Eco-friendly HPLC Methods Using Refractive Index Detector for Analysis of Three Veterinary Antibiotics in Pharmaceutical Formulations and Rat Plasma.

作者信息

Gamal Mohammed, Elhalim Lobna Mohammed Abd

机构信息

Pharmaceutical Chemistry Department, Faculty of Pharmacy, Jouf University, 2014, Sakaka, Aljouf, Saudi Arabia.

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmed Hegazy St., 62574 Beni-Suef, Egypt.

出版信息

J Chromatogr Sci. 2020 Oct 26;58(10):940-950. doi: 10.1093/chromsci/bmaa065.

DOI:10.1093/chromsci/bmaa065
PMID:32901249
Abstract

Antibiotic resistance increases the human mortality rate nowadays. The main purpose of the present study was to develop green reversed-phase high-performance liquid chromatography (RP-HPLC) methods with a refractive index detector for the assay of the three veterinary antibiotics (VAs), i.e., maduramicin ammonium (MA), apramycin sulfate (AS) and clarithromycin (CLA) in pharmaceutical dosage forms and spiked rat plasma. The method utilized isocratic elution using an ODP-40 C18 column, the flow rate was set at 1.0 mL/min and negative polar signals. The linearity ranges were 3.0-18.0 μg/mL for MA, 1.5-4.0 μg/mL for AS and 0.5 to 3.0 μg/mL for CLA, respectively. Liquid-liquid extraction (LLE) procedure was optimized in plasma samples. The recoveries percentages were 85.4, 81.2 and 88.8 correspondingly, in rat plasma. However, the drugs extraction by protein precipitation method yields very poor recoveries (around 50%). The new HPLC- refractive index (RI) methods are better than the previously reported HPLC-ultra violet methods in terms of greenness and simplicity of procedures. Moreover, the previously reported LC-MS methods lack the simplicity and availability of such expensive techniques in Quality control (QC) labs. The novelty of this research is the use of refractive index detector for the first time for VAs analysis.

摘要

如今,抗生素耐药性提高了人类死亡率。本研究的主要目的是开发采用示差折光检测器的绿色反相高效液相色谱(RP-HPLC)方法,用于测定药物剂型和加标大鼠血浆中的三种兽用抗生素(VAs),即马杜霉素铵(MA)、硫酸安普霉素(AS)和克拉霉素(CLA)。所采用的方法是使用ODP-40 C18柱进行等度洗脱,流速设定为1.0 mL/min,并采集负极信号。MA的线性范围分别为3.0 - 18.0 μg/mL,AS为1.5 - 4.0 μg/mL,CLA为0.5至3.0 μg/mL。对血浆样品中的液-液萃取(LLE)程序进行了优化。在大鼠血浆中,回收率分别为85.4%、81.2%和88.8%。然而,通过蛋白质沉淀法提取药物的回收率非常低(约50%)。新的HPLC-示差折光(RI)方法在绿色环保和操作简便性方面优于先前报道的HPLC-紫外方法。此外,先前报道的LC-MS方法在质量控制(QC)实验室中缺乏这种昂贵技术的简便性和实用性。本研究的新颖之处在于首次使用示差折光检测器对兽用抗生素进行分析。

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