Please use this identifier to cite or link to this item: http://hdl.handle.net/20.500.12188/12943
Title: Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets
Authors: Ivana Mitrevska, Tina Achkoska, Katerina Brezovska, Krume Toshev, Aneta Dimitrovska, Sonja Ugarkovic
Keywords: Metformin Hydrochloride; BCS class III active substance; immediate-release tablets; discriminative dissolution method; validation parameters
Issue Date: 10-Dec-2019
Publisher: Hindawi Journal of Analytical Methods in Chemistry
Source: Ivana Mitrevska, Tina Achkoska, Katerina Brezovska, Krume Toshev, Aneta Dimitrovska, Sonja Ugarkovic, "Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets", Journal of Analytical Methods in Chemistry, vol. 2019, Article ID 4296321, 8 pages, 2019. https://doi.org/10.1155/2019/4296321
Journal: Journal of Analytical Methods in Chemistry
Series/Report no.: ;Article ID 4296321
Abstract: The purpose of this study was to develop and validate a discriminative dissolution method for Metformin film-coated tablet with immediate-release of the active substance that belongs to class III of the Biopharmaceutical Classification System (BCS). Different conditions such as: type of dissolution medium, volume of dissolution medium, rotation speed, apparatus and filter suitability were evaluated. The most discriminative release profile for Metformin film-coated tablet was accomplished by using Apparatus II (paddle), 1000 mL of phosphate buffer pH 6.8 as dissolution medium, maintained on 37 ± 0.5 °C and rotation speed of 75 rpm. The quantification of the released active substance was performed by UV-Vis spectrophotometry, at 232 nm. Acceptance criteria for not less than 80% (Q+5%) of the labeled content for 45 minutes were set. The dissolution method was validated according to current international guidelines using parameters: specificity, accuracy, precision, linearity, robustness and stability of the solutions, found to be meeting the predetermined acceptance criteria. A developed dissolution method has discriminatory power to reflect the characteristics of the medicinal product and is able to distinguish any changes related to quantitative formulation and can be also applied for routine batch testing.
URI: http://hdl.handle.net/20.500.12188/12943
DOI: https://doi.org/10.1155/2019/4296321
Appears in Collections:Faculty of Pharmacy: Journal Articles

Files in This Item:
File Description SizeFormat 
Development and Validation of Discriminative Dissolution Method.pdf1.69 MBAdobe PDFView/Open
Show full item record

Page view(s)

46
checked on Jun 27, 2022

Download(s)

9
checked on Jun 27, 2022

Google ScholarTM

Check

Altmetric


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.