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一种用于测定原料药和眼用溶液中奈替米星的简单环保型稳定性指示高效液相色谱法。

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

作者信息

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

机构信息

Faculty of Science, Zagazig University, Zagazig, Egypt.

Egyptian International Pharmaceutical Industries (EIPICO) Company, 10th of Ramadan City, Egypt.

出版信息

Biomed Chromatogr. 2025 Aug;39(8):e70152. doi: 10.1002/bmc.70152.

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.

摘要

我们研究的目的是开发并验证一种环保的稳定性指示方法,用于测定原料药和眼用溶液中的奈替米星。流动相由40 mL乙醇和960 mL pH为3.5的缓冲溶液组成,该缓冲溶液用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,进样体积为20 μL,分析运行时间<7 min,重点关注奈替米星浓度水平为125.0 - 1000.0 μg/mL。该方法的环境友好性通过以下结果得到证明:AES为87、AGREE为0.65、MoGAPI为76(有六个绿色项)、BAGI评分为77.5以及白度为99.2。所提供的方法具有诸多优异特性,包括成本效益、符合国际协调会议(ICH)验证项目以及环境友好性。

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