介孔二氧化硅纳米颗粒基质中喜树碱及其降解产物定量的高效液相色谱法

IF 1.7 4区 农林科学 Q3 CHEMISTRY, ANALYTICAL
Richa Dave, Neel Savaliya, Ashish Dobariya, Rashmin Patel, Mrunali Patel
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引用次数: 0

摘要

背景 喜树碱是一种用于治疗各种癌症的强效抗癌药物。本研究调查的目的是开发和验证一种新的稳定性指示高效液相色谱技术,用于定量评估内部开发的介孔二氧化硅纳米粒子(一种用于治疗癌症的新型纳米制剂基质)中的喜树碱含量。方法 采用 Waters Inertsil® HPLC 色谱柱(C18)进行色谱分离,流速为 1 mL/min,柱温为 40 ℃,进样量为 10 µL,检测波长为 216 nm,总运行时间为 10 分钟。流动相为等度混合磷酸盐缓冲液(10 mM,pH7.0)和乙腈(60:40 v/v)。在各种压力条件下,包括酸、碱、氧化、光解、热和湿度环境下,采用该方法对喜树碱进行了定量检测。结果表明该方法特异性好(峰纯度≥0.999)、准确度高(99.69-100.64% w/w)、精密度高(%RSD < 2.0)、灵敏度高(LOD-0.17 µg,LOQ-0.56 µg),符合ICH Q2(R1)指南的要求。任何不明降解产物都不会干扰药物的估计。此外,目前的分析方法消除了制剂基质中多种辅料造成的基质效应干扰。结论 为了对喜树碱进行常规定量分析,本研究工作提供了一种新颖而简单的高效液相色谱法,并对色谱参数进行了优化,从而为研发界做出了贡献,同时确保了通过各种纳米制剂对该药物进行适当而有效的使用,从而达到治疗癌症的目的。亮点 稳定性指示高效液相色谱法具有特异性,适用于喜树碱的常规分析。强制降解研究证实该方法不受辅料干扰。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Robust HPLC Approach for Quantitation of Camptothecin in Mesoporous Silica Nanoparticles Matrix and in the Presence of Its Degradation Products
Background Camptothecin is a potent anti-cancer drug used for the treatment of various cancers. Objective The goal of this research investigation was to develop and validate a new stability indicating HPLC technique for the quantitative assessment of camptothecin in in-house developed mesoporous silica nanoparticles, a novel nanoformulation matrix for the treatment of cancer. Method The Waters Inertsil® HPLC column (C18) was used for the chromatographic separation, with a flow rate of 1 mL/min, a column oven temperature of 40 °C, an injection volume of 10 µL, a detection wavelength of 216 nm, and a 10 min runtime overall. An isocratic blend of phosphate buffer (10 mM, pH7.0) and acetonitrile (60:40 v/v) served as the mobile phase. Various stress conditions including acid, alkali, oxidative, photolytic, thermal, and humidity environments were tested for the quantitative estimation of the camptothecin through the proposed method. Results The results demonstrated that the proposed method is specific (peak purity ≥ 0.999), accurate (99.69—100.64% w/w), precise (%RSD < 2.0), and sensitive (LOD—0.17 µg and LOQ—0.56 µg) in accordance with ICH guideline Q2(R1). Any unidentified degradation products did not interfere with the drug's estimation. Furthermore, the current method of analysis has eliminated any excipient interference from the matrix effect caused by the numerous excipients of the formulation matrix. Conclusions To quantify camptothecin for routine assay purposes, this research work offers a novel and straightforward HPLC methodology with optimized chromatographic parameters, contributing to the research and development community while ensuring an appropriate and efficient use of the drug through a variety of nanoformulation for cancer treatment. Highlights Stability-indicating HPLC method was found to be specific and suitable for routine analysis of camptothecin. The absence of any interference from excipients was confirmed by forced degradation studies.
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来源期刊
Journal of AOAC International
Journal of AOAC International 医学-分析化学
CiteScore
3.10
自引率
12.50%
发文量
144
审稿时长
2.7 months
期刊介绍: The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.
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