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Evaluation of cefaclor oral suspensions stability using reversed phase high performance liquid chromatography and
Khaled Ahmad Tarawneh1, Zina Atallah Halasah, Ali Mohmad Khleifat
1Department of Biology, Mutah University, Karak, Mutah, Jordan. tarawneh@MUTAH.EDU.JO
Pakistan Journal of Pharmaceutical Sciences
|July 1, 2011
Summary
Cefaclor suspensions stored at 4°C showed minimal degradation (<5%) over 14 days, indicating good stability for pediatric use. Higher temperatures increased degradation, but most formulations remained within pharmacopoeial limits.
Area of Science:
- Pharmaceutical Sciences
- Analytical Chemistry
- Microbiology
Background:
- Cefaclor is a widely used antibiotic, and its stability in suspension form is crucial for effective pediatric treatment.
- Temperature variations can significantly impact the degradation rate and antimicrobial efficacy of antibiotic suspensions.
Purpose of the Study:
- To evaluate the effect of different storage temperatures (4°C, 25°C, 37°C) on the stability and degradation of Cefaclor pediatric suspensions over 14 days.
- To assess the antimicrobial activity of Cefaclor suspensions post-storage.
- To determine if Jordanian Cefaclor suspensions meet United States Pharmacopoeia (USP) and British Pharmacopoeia (BP) standards.
Main Methods:
- Cefaclor suspensions were subjected to temperature stresses for 14 days.
- Degradation was quantified using a validated Reversed-Phase High-Performance Liquid Chromatographic (RP-HPLC) method.
- Antimicrobial activity was tested against pathogenic bacteria using the cylinder diffusion method.
Main Results:
- At 4°C, degradation was less than 5% for most Cefaclor suspensions (Forticef, Midocef, Ceclor) after 14 days.
- Cefabac and Cloracef showed slightly higher degradation (5-6%) at 4°C.
- Higher temperatures (25°C, 37°C) generally led to significant degradation and loss of antimicrobial activity, with some variations between brands.
Conclusions:
- Pediatric Cefaclor suspensions available in the Jordanian market are generally stable under recommended storage conditions (4°C).
- The analyzed Cefaclor suspensions comply with USP and BP specifications for active ingredient content.
- Temperature control is essential to maintain the efficacy and safety of Cefaclor suspensions.
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