Accelerated stability and antimicrobial sensitivity studies of amoxicillin dry suspensions marketed in Bangladesh.
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Date
2011-11
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Abstract
Since its introduction, amoxicillin dry suspension has been the mainstay for the
antibacterial therapy for paediatric patients. But use of substandard preparation of antibiotic is
one of the most important causes of microbial resistance. The present study has been carried out
to evaluate the quality and stability status of 10 marketed amoxicillin dry suspensions of
Bangladesh. All the brands were analyzed for their potency using chemical and microbiological
methods described in the United States Pharmacopoeia and British Pharmacopoeia. Potency
determination was done at three controlled temperatures - refrigerated, room and elevated (40C)
showed that two samples were over potent but one sample was substandard out of the 10
samples. The initial potencies of the two samples were within USP range when freshly
reconstituted but after 7 days, at room temperature, potencies deteriorated and came down to
90%. In refrigerated condition, all the samples remained in good condition and at 40C, a
considerable loss of potencies in all the samples were observed. Results of microbiological assay
also support the results of chemical assay. The study emphasizes the necessity of routine
inspection, monitoring and evaluation of quality of formulations containing amoxicillin dry
syrup.
Description
Keywords
Amoxicillin, dry suspension, paediatric patients, substandard, reconstituted
Citation
Haider Syed Shabbir, Nasrin Nishat, Apu Apurba Sarker, Asaduzzaman Muhammad. Accelerated stability and antimicrobial sensitivity studies of amoxicillin dry suspensions marketed in Bangladesh. Journal of Applied Pharmaceutical Science. 2011 Nov; 1(9): 51-55.