A Simple Eco-Friendly Stability-Indicating HPLC Method for Determination of NETILMICIN in Bulk and Ophthalmic Solution

IF 1.8 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS

Biomedical Chromatography Pub Date : 2025-06-23 DOI:10.1002/bmc.70152

Ahmed Sobhy Darwish, Mohamed Samir Ahmed Zaki, Ali GadKarim A. Salih, Mohamed Abd Ellatif, Ayyub Ali Patel, Ayaz Khurram Mallick, Marya Ahsan, Wageh Sobhy Darwish

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Abstract

The aim of our study was the development and validation of an eco-friendly stability-indicating method for the determination of netilmicin in bulk and in ophthalmic solution. The mobile phase was composed of 40-mL ethanol and 960-mL buffer solution at a pH of 3.5, which was prepared by using 1-hexane sodium sulfonate and anhydrous sodium sulfate, at a flow rate of 1 mL/min. The detecting wavelength was 205 nm, the injection volume was 20 μL, the analysis runtime was < 7 min, and the focus was on netilmicin concentration levels of 125.0–1000.0 μg/mL. The method's environmental friendliness was demonstrated by the conclusional AES of 87, the AGREE of 0.65, the MoGAPI of 76 with six green pieces, the BAGI score of 77.5, and the whiteness of 99.2. The method that is being provided demonstrates exceptional attributes including cost-effectiveness, ICH validation items, and environmental friendliness.

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一种简便、环保、稳定性指示的高效液相色谱法测定原料药和眼药水中奈替米星的含量

本研究的目的是建立和验证一种环保的稳定性指示方法，用于测定原料药和眼液中奈替米星的含量。流动相为40-mL乙醇和960-mL缓冲液，pH为3.5，以1-己烷磺酸钠和无水硫酸钠配制，流速为1 mL/min。检测波长为205 nm，进样量为20 μL，分析时间为7 min，重点检测奈替米星浓度范围为125.0 ~ 1000.0 μg/mL。结果表明，该方法具有良好的环境友好性，AES为87，AGREE为0.65，MoGAPI为76，有6个绿色块，BAGI得分为77.5，白度为99.2。所提供的方法展示了特殊的属性，包括成本效益、ICH验证项目和环境友好性。

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来源期刊

Biomedical Chromatography 生物-分析化学

CiteScore

3.60

自引率

5.60%

发文量

268

审稿时长

2.3 months

期刊介绍： Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.