Development and Validation of RP-HPLC Method for Estimation of Methotrexate Drug Intercalated in Mg-Al Layered Double Hydroxide Nanoparticles

IF 1.5 4区材料科学 Q3 MATERIALS SCIENCE, CERAMICS

Transactions of the Indian Ceramic Society Pub Date : 2021-04-03 DOI:10.1080/0371750X.2021.1904291

A. Basu, Sayantan Ray, S. Saha, J. Chakraborty

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Abstract

In the present study, pristine magnesium aluminium layered double hydroxide (Mg-Al LDH, sample A) nanoparticles were synthesized by simple co-precipitation technique followed by intercalation of methotrexate drug (MTX), their detailed physicochemical characterization and development of RP-HPLC method for estimation of MTX intercalated in Mg-Al LDH nanoparticles (sample B). The PXRD analysis showed the basal spacing of 003 plane corresponding to sample A and sample B to be 8.63 Å and 11.39 Å, respectively. Particle size distributions were measured to be 56-75 nm (D50=66.15 nm) in case of sample A and 75-100 nm (D50=87.41 nm) for sample B. Simple, accurate RP-HPLC method was developed for estimation of the MTX drug from sample B, on Agilent HPLC 1200 system with UV detector on L1 column. 0.02 M potassium dihydrogen phosphate solution (pH 3.0) and acetonitrile (85:15 v/v) was used as mobile phase in an isocratic elution mode at a flow rate of 1.0 mL/min at 35°C with a load of 10 μL at 307 nm. The retention time for methotrexate was at 4.44 min. The method was validated as per ICH Q2 (R1) guidelines. The method was found to be linear over a concentration range of 10-100 μg/mL. GRAPHICAL ABSTRACT

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反相高效液相色谱法测定Mg-Al层状双氢氧化物纳米粒子中甲氨蝶呤药物的含量

在本研究中，通过简单的共沉淀技术，然后嵌入甲氨蝶呤药物（MTX），合成了原始的镁铝层状双氢氧化物（Mg-Al-LDH，样品A）纳米颗粒，对其进行了详细的物理化学表征，并开发了RP-HPLC法来估计嵌入Mg-Al-LLDH纳米颗粒中的MTX（样品B）。PXRD分析显示，对应于样品A和样品B的003平面的基底间距分别为8.63Å和11.39Å。在样品A的情况下，粒度分布测量为56-75nm（D50=66.15nm），在样品B的情况下为75-100nm（D50=87.41nm）。在安捷伦HPLC 1200系统上，用L1柱上的UV检测器，开发了简单、准确的RP-HPLC方法来估计样品B中的MTX药物。0.02M磷酸二氢钾溶液（pH 3.0）和乙腈（85:15v/v）作为流动相，以等度洗脱模式，流速为1.0mL/min，温度为35°C，负载量为10μL，波长为307nm。甲氨蝶呤的保留时间为4.44分钟。该方法根据ICH Q2（R1）指南进行验证。该方法在10-100μg/mL的浓度范围内呈线性。图形摘要

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来源期刊

Transactions of the Indian Ceramic Society 工程技术-材料科学：硅酸盐

CiteScore

2.40

自引率

8.30%

发文量

审稿时长

2.3 months

期刊介绍： Transactions of the Indian Ceramic Society is a quarterly Journal devoted to current scientific research, technology and industry-related news on glass and ceramics. The Journal covers subjects such as the chemical, mechanical, optical, electronic and spectroscopic properties of glass and ceramics, and characterization of materials belonging to this family. The Editor invites original research papers, topical reviews, opinions and achievements, as well as industry profiles for publication. The contributions should be accompanied by abstracts, keywords and other details, as outlined in the Instructions for Authors section. News, views and other comments on activities of specific industries and organizations, and also analyses of industrial scenarios are also welcome.