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

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.