Stability studies of reconstituted oral amoxicillin suspension (125mg/5ml) under different temperature storage conditions

Abstract

The research objective was to determine the physical stability and concentration of amoxicillin reconstituted oral suspension (125mg/5ml) stored under room temperature of 25°C and refrigeration temperature of 2-8°C for day 1, 3, and 7. Three different brands of amoxicillin samples were used. Samples from the reconstituted amoxicillin suspension was assayed by HPLC to determine the concentration of the active and examined physically for taste, odour and colour change. Reconstituted antibiotic suspensions must be stored at room temperature or in a refrigerator to maintain potency throughout their use. However, a good number of patients do not adhere to storage specifications resulting in the degradation of the product and subsequent loss of potency. The drug concentration for all three brands during the days analysed ranged from 88.94-102.17(%) for refrigerated and 89.57-99.7(%) for reconstituted amoxicillin at room temperature. The odour for days 1, 3 and 7 is fruity. The colour was pale yellow for days 1 and 3, while on day 7, it was creamy yellow. The taste was sweet on days 1 and 3, while on day 7, it was sweet/low bitter. The three brands maintained their potency and physical stability as required in the British pharmacopoeia. The results for day one for all the drugs fall within the accepted range. Drug K has its percent concentration the lowest. Microbiological studies is recommended for the drug to ascertain its microbial stability.