Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets
المؤلفون المشاركون
Ugarkovic, Sonja
Dimitrovska, Aneta
Mitrevska, Ivana
Achkoska, Tina
Toshev, Krume
Brezovska, Katerina
المصدر
Journal of Analytical Methods in Chemistry
العدد
المجلد 2019، العدد 2019 (31 ديسمبر/كانون الأول 2019)، ص ص. 1-8، 8ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2019-12-10
دولة النشر
مصر
عدد الصفحات
8
التخصصات الرئيسية
الملخص EN
The purpose of this study was to develop and validate a discriminative dissolution method for the 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 the metformin film-coated tablet was accomplished by using Apparatus II (paddle) and 1000 mL of phosphate buffer pH 6.8 as the dissolution medium and maintained on 37 ± 0.5°C with a 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 75% (Q) of the labeled content for 45 minutes were set.
The dissolution method was validated according to the current international guidelines using the following 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.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Mitrevska, Ivana& Achkoska, Tina& Brezovska, Katerina& Toshev, Krume& Dimitrovska, Aneta& Ugarkovic, Sonja. 2019. Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets. Journal of Analytical Methods in Chemistry،Vol. 2019, no. 2019, pp.1-8.
https://search.emarefa.net/detail/BIM-1169142
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Mitrevska, Ivana…[et al.]. Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets. Journal of Analytical Methods in Chemistry No. 2019 (2019), pp.1-8.
https://search.emarefa.net/detail/BIM-1169142
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Mitrevska, Ivana& Achkoska, Tina& Brezovska, Katerina& Toshev, Krume& Dimitrovska, Aneta& Ugarkovic, Sonja. Development and Validation of Discriminative Dissolution Method for Metformin Immediate-Release Film-Coated Tablets. Journal of Analytical Methods in Chemistry. 2019. Vol. 2019, no. 2019, pp.1-8.
https://search.emarefa.net/detail/BIM-1169142
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1169142
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر