一种与环境评估工具相结合的兽医配方的 HPLC 全面分析。

A Thorough HPLC Assay of Quaternary Veterinary Formulation coupled with Environmental Assessment Tool.

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, Ahram Canadian University, 12566, 6th October City, Giza, Egypt.

Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, 11562, Cairo, Egypt.

出版信息

J Chromatogr Sci. 2021 Aug 18;59(8):776-784. doi: 10.1093/chromsci/bmaa135.

DOI:10.1093/chromsci/bmaa135

PMID:33501485

Abstract

A new and accurate reversed phase HPLC method with UV detection has been established for any veterinarian analyst for simultaneous determination of a veterinary quaternary mixture of sulphadimidine sodium (SDS), sulphaquinoxaline sodium (SQS), diaveridine (DVD) and vitamin K3 (VTK3) in their formulation. The stationary phase was SEA C18 column (250 × 4.6 mm i.d., 5 μm particle size) at 25°C with an isocratic mode, using a mobile phase containing a mixture of methanol:acetonitrile:distilled water in the ratio of (20:20:60, by volume). The flow rate was 0.8 mL min-1, and UV detection was performed at 230 nm. The HPLC assay was coupled with Environmental Assessment Tool (EAT), which represents a simple and proficient approach for profiling the greenness of the method. This takes into consideration the environmental, health and safety issues for all solvents that involved in the chromatographic method and calculates a total score that can be used for comparison of the greenness of different methods. The method was found to be linear over (0.5-30) μg/mL for all cited drugs with mean percentage recoveries (99.56 ± 1.141) for VTK3, (99.56 ± 1.056) for DVD, (99.62 ± 1.482) for SDS and (99.52 ± 1.205) for SQS. The results were statistically compared with those of the official and reported methods; using Student's t-test and F-test, showing no significant difference with respect to accuracy. Specificity of the applied method was assessed by analyzing the laboratory-prepared mixtures. The developed method was validated according to ICH guidelines. The proposed methodology can be applied for rapid routine assay of this combination.

摘要

建立了一种新的、准确的反相高效液相色谱法（HPLC），并用紫外检测法（UV），以供任何兽医分析人员同时测定兽医磺胺二甲嘧啶钠（SDS）、磺胺喹恶啉钠（SQS）、二甲氧苄啶（DVD）和维生素 K3（VTK3）的四元混合物在其制剂中的含量。固定相为 SEA C18 柱（250×4.6mm id，5μm 粒径），在 25°C 下采用等度模式，流动相由甲醇:乙腈:蒸馏水（体积比 20:20:60）组成。流速为 0.8mL min-1，UV 检测波长为 230nm。HPLC 分析与环境评估工具（EAT）相结合，EAT 代表了一种简单高效的方法，可用于分析方法的绿色程度。它考虑了色谱方法中涉及的所有溶剂的环境、健康和安全问题，并计算出一个总得分，可用于比较不同方法的绿色程度。该方法对所有引用药物在（0.5-30）μg/mL 范围内均呈线性，VTK3 的平均回收率为（99.56±1.141）%，DVD 为（99.56±1.056）%，SDS 为（99.62±1.482）%，SQS 为（99.52±1.205）%。结果与官方和报道的方法进行了统计学比较；使用学生 t 检验和 F 检验，结果表明在准确性方面无显著差异。通过分析实验室制备的混合物来评估所应用方法的特异性。根据 ICH 指南对所建立的方法进行了验证。该方法可用于快速常规测定该组合。