Development and validation of a dissolution test for andrographolide dispersible tablets using UV-Vis spectrophotometry

IF 0.5 Q4 EDUCATION, SCIENTIFIC DISCIPLINES

Pharmacy Education Pub Date : 2024-06-14 DOI:10.46542/pe.2024.246.2834

Evieta Rohana, Nuraini Ekawati, Insilia Ivanna Hapsari

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引用次数: 0

Abstract

Background: Andrographolide, a terpenoid in an herbal plant, potentially has antidiabetic properties. Dispersible tablets are one of the pharmaceutical dosage forms used to improve acceptability. It is necessary to evaluate the dissolution profile to ensure the drug’s efficacy. Objective: This study aimed to determine the optimum condition of a dissolution test and its analysis for andrographolide dispersible tablets. Method: The optimisation process involves varying solvents, pH, and mole ratio of ARS-Cu(II)-andrographolide to determine the best conditions for the dissolution test of andrographolide dispersible tablets. Validation and analysis are conducted using spectrophotometry UV-Vis. Results: The optimal condition for the dissolution test was obtained with type II at 75 rpm, 900ml of citrate buffer medium with pH 3.1, and a temperature of 37±0.5ºC. The optimal analysis condition for the aliquot was obtained with Cu(II) metal and ARS reagents at pH 7, mole ratio 6:1:1.8, and a 15-minute optimum time. The maximum wavelength was 518nm using a UV-Vis spectrophotometer. The validation method has met the requirements. Conclusion: A dissolution test and its analytical method of andrographolide dispersible tablet have been validated.

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利用紫外可见分光光度法开发和验证穿心莲内酯分散片的溶出试验

背景：穿心莲内酯是一种草本植物中的萜类化合物，可能具有抗糖尿病特性。分散片是提高药物可接受性的药物剂型之一。有必要对溶解度进行评估，以确保药物的疗效：本研究旨在确定穿心莲内酯分散片溶出试验的最佳条件及其分析方法：优化过程包括改变溶剂、pH 值和 ARS-Cu(II)-穿心莲内酯的摩尔比，以确定穿心莲内酯分散片溶出试验的最佳条件。使用分光光度法 UV-Vis 进行验证和分析：溶出试验的最佳条件为：Ⅱ型，转速为 75 转/分，900 毫升 pH 值为 3.1 的柠檬酸盐缓冲介质，温度为 37±0.5℃。等分试样的最佳分析条件是使用金属铜（II）和 ARS 试剂，pH 值为 7，摩尔比为 6:1:1.8，最佳时间为 15 分钟。使用紫外可见分光光度计测定的最大波长为 518 纳米。验证方法符合要求：穿心莲内酯分散片的溶出试验及其分析方法已通过验证。

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来源期刊

Pharmacy Education EDUCATION, SCIENTIFIC DISCIPLINES-

CiteScore

0.80

自引率

20.00%

发文量

174

期刊介绍： Pharmacy Education journal provides a research, development and evaluation forum for communication between academic teachers, researchers and practitioners in professional and pharmacy education, with an emphasis on new and established teaching and learning methods, new curriculum and syllabus directions, educational outcomes, guidance on structuring courses and assessing achievement, and workforce development. It is a peer-reviewed online open access platform for the dissemination of new ideas in professional pharmacy education and workforce development. Pharmacy Education supports Open Access (OA): free, unrestricted online access to research outputs. Readers are able to access the Journal and individual published articles for free - there are no subscription fees or ''pay per view'' charges. Authors wishing to publish their work in Pharmacy Education do so without incurring any financial costs.