| Autor: |
Krešić, D., Džambić, M., Ćatović, E., Alagić-Džambić, L., Pašić-Kulenović, M. |
| Předmět: |
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| Zdroj: |
Bulletin of the Chemists & Technologists of Bosnia & Herzegovina / Glasnik Hemičara i Tehnologa Bosne i Hercegovine; 2018 Special Issue, p32-32, 1p |
| Abstrakt: |
The purpose of stability testing is to provide evidence on how the quality of drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Stability data establish shelf life for the drug product and recommended storage conditions. Alpha lipoic acid (ALA) is a mitochondrial compound and body's natural antioxidant. The aim of this study was to evaluate the stability and quality of ALA tablets in dosage form of 600 mg. Tablets were packed in two different primary packaging materials: PVC/PVdC/Al blisters and amber glass flask and stored at accelerated (40°C/75%RH) and long-term (25°C/60%RH) storage conditions and analyzed after 3 and 6 months of storage. The effects of environmental factors on ALA tablets in two different packaging materials were investigated by HPLC method. The HPLC analysis was performed using a C18 column 150 x 4.0 mm x 5 μm, setting the flow at 1.5 mL/min and the UV detector at 220 nm. The results showed a significant decrease of ALA content and dissolution in tablets, packed in PVC/PVdC/Al blisters. Amber glass flask maintained better pharmaceutical performance of the tested product (after 3 and 6 months). [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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