Implementation of Quality by Design Approaches for Development and Validation of Reverse-Phase High-Performance Liquid Chromatography Assay Method for Determination of Glycyrrhizin in Nanoformulation.

IF 1.6 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS

Assay and drug development technologies Pub Date : 2024-01-01 Epub Date: 2023-12-26 DOI:10.1089/adt.2023.087

Jitu Halder, Ivy Saha, Tushar Kanti Rajwar, Biswakanth Kar, Goutam Ghosh, Goutam Rath

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引用次数: 0

Abstract

Glycyrrhizin (GL) is the principal constituent of Glycyrrhiza glabra, having antiallergic, anticancer, anti-inflammatory, and antimicrobial action. The reverse-phase high-performance liquid chromatography (RP-HPLC) analytical method was used to quantitatively estimate GL in a nanoformulation and validated as per International Conference on Harmonization Q2 (R1) standards. A stationary phase of the C18-HL reversed-phase column and a mobile phase of acetonitrile and water were used for effective elution. The chromatographic conditions of RP-HPLC were optimized utilizing a quality-by-design approach to accomplish the required chromatographic separation of GL from its nanoformulation with minimal experimental runs. Optimized RP-HPLC conditions for the assay method consist of acetonitrile (41%) and water, pH 1.8, balanced with phosphoric acid (0.1%) as a mobile phase with a flow rate of 1 mL/min. The retention time was found at 7.25 min, and method validation confirmed its sensitivity, preciseness, accuracy, and robustness.

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采用 "质量源于设计 "方法开发和验证用于测定纳米制剂中甘草苷的反相高效液相色谱分析方法

甘草苷（Glycyrrhizin，GL）是甘草的主要成分，具有抗过敏、抗癌、抗炎和抗菌作用。本研究采用反相高效液相色谱法（RP-HPLC）对纳米制剂中的甘草苷进行定量测定，并按照国际协调会议 Q2 (R1) 标准进行了验证。采用 C18-HL 反相色谱柱作为固定相，乙腈和水作为流动相进行有效洗脱。采用 "质量源于设计 "的方法优化了 RP-HPLC 的色谱条件，从而以最少的实验次数从纳米制剂中分离出所需的 GL。优化后的 RP-HPLC 检测条件为：流动相为乙腈（41%）和水（pH 值为 1.8），流动相为磷酸（0.1%），流速为 1 mL/min。该方法的保留时间为 7.25 分钟，其灵敏度、精确度、准确度和稳健性均通过了方法验证。

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来源期刊

Assay and drug development technologies 医学-生化研究方法

CiteScore

3.60

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： ASSAY and Drug Development Technologies provides access to novel techniques and robust tools that enable critical advances in early-stage screening. This research published in the Journal leads to important therapeutics and platforms for drug discovery and development. This reputable peer-reviewed journal features original papers application-oriented technology reviews, topical issues on novel and burgeoning areas of research, and reports in methodology and technology application. ASSAY and Drug Development Technologies coverage includes: -Assay design, target development, and high-throughput technologies- Hit to Lead optimization and medicinal chemistry through preclinical candidate selection- Lab automation, sample management, bioinformatics, data mining, virtual screening, and data analysis- Approaches to assays configured for gene families, inherited, and infectious diseases- Assays and strategies for adapting model organisms to drug discovery- The use of stem cells as models of disease- Translation of phenotypic outputs to target identification- Exploration and mechanistic studies of the technical basis for assay and screening artifacts