TITLE

STABILITY OF RECONSTITUTED CEFUROXIME AXETIL AT DIFFERENT TEMPERATURE STORAGE CONDITIONS

AUTHOR(S)
Al Zomor, Adulkarim Kassem Yehia; Alakhali, Khaled Mohammad Ahmad; Mekhlafi, Ahmed Galeb Al
PUB. DATE
January 2013
SOURCE
Pharmacie Globale;Jan2013, Vol. 4 Issue 1, p1
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Oral suspensions of antibiotics are mainly available as dry powders for reconstitution; many reconstituted antibiotic suspensions are to be kept refrigerated in order to get the optimal benefit from the drug. However, many patients do not keep to the specified storage conditions for different reasons like no refrigerator and irregular power supply that may result in various degrees of degradation of the product. The aim of the study was to determine the stability of cefuroxime axetil (Brand name) oral suspension (125mg/5ml) at different temperature storage conditions (stored at room temperature/25°C and refrigerated 2-8°C conditions). This study investigated stability of cefuroxime axetil oral suspension at different temperature storage conditions of erratic power supply and no refrigeration. Three different batches from cefuroxime axetil 125mg/5ml oral suspensions (Zinnat) were reconstituted and stored in refrigerator (2-8°C) and the same batches are stored at room temperature 25°C over a period of 14 days. Samples from the suspension were assayed using a validated HPLC method and the concentration and percentage dissolution of cefuroxime axetil were measured using HPLC and UV spectrophotometer. Reconstituted cefuroxime axetil stored at refrigerator (2-8°C) is stable for 10 days over 90%, after that start to degradation and also the percentage dissolution over 60% for the first 10 days after that less than 60% outside the acceptance limits of USP. While concentration percentage of cefuroxime axetil stored at room temperature were over 90% up to 5th day, degradation was extensive by 7th day with cefuroxime axetil concentration falling to 80% outside the acceptance limits and percentage dissolution over 60% for the first 3 days after that the amount of dissolved drug was less than 60% and reach to 33% outside the acceptance limits of USP. Cefuroxime axetil suspension after reconstitution was found stable for 10 days, if stored at refrigerated condition but 3 days only at room temperature.
ACCESSION #
87977553

 

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