Quality and Stability of Amoxicillin-Potassium Clavulanate Drugs Marketed in Yemen: Influence of Tropical Storage Conditions

Abstract

The study objective is to assess the quality and stability of amoxicillin-potassium clavulanate products. HPLC Method was used for drug content and in vitro dissolution tests that were performed on 10 generic products registered and marketed in city of Sana'a at purchase time, after one month, three months and six months storage under simulated tropical conditions (40 �2�C and 75 �5% RH) according to USP30. The results of study has shown that 2 of 10 tested products had a poor quality at purchase time which one was lower than limit and the another was upper than limit. After six months storage 4 of 10 and 7 of 10 of the tested products were fail in amoxicillin and clavulanate content respectively, and 7 of 10, and 8 of 10 of the tested products were fail in amoxicillin and clavulanate release after 30 min respectively. Study shown that 8 of 10 (80%) of tested products was substandard and don�t comply with USP30. Good manufacturing process and storage conditions may affect the quality of amoxicillin-potassium clavulanate products in Yemeni market. Stringent quality control measures and stability tests should be applied to maintain the quality of amoxicillin-potassium clavulanate products in the market.