Pharmacophore an International Research Journal
Stability is the ability of a drug substance or drug product to persist within the established specifications, to sustain its physicochemical and pharmacological properties throughout its shelf life. Drugs can be degraded when exposed to conditions that are not suitable or labeled for it. Co-amoxiclav (amoxicillin-clavulanate potassium) samples of 7 brands (Amoxicillin: 125mg/5ml, Clavulanic Acid: 31.25mg/5ml) were evaluated to determine the parameters such as physical description (color, odor, and taste), pH, water content, and drug content analysis at days 0, 15, 30 and 45. The results showed that most of the variations were observed at day 45 of the storage of the drug product. It was concluded that the storage conditions at pharmacies/ medical stores are not fulfilling the regulatory guidelines which contributed to degrading the drug content of co-amoxiclav dry powder for suspension for oral utilization.
