Stability studies of reconstituted oral amoxicillin suspension (125mg/5ml) under different temperature storage conditions
Keywords:amoxicillin, refrigerated temperature, room temperature, stability
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 days 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. The drug concentration for all three brands during the seven days ranged from 88.94 per cent - 102.17 per cent for refrigerated and 89.57-99.7 per cent 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 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 results for day one for all the drugs fall within the accepted range, drug K has its percent concentration the lowest, and microbiological studies should be done on this drug to ascertain microbial stability.