DEVELOPMENT AND VALIDATION OF MICROBIAL BIOASSAY FOR QUANTIFICATION OF CEPHALEXIN IN PHARMACEUTICAL PREPARATIONS

G Rohit Reddy, Chavi Dagar, Ramesh T
2017 International Research Journal of Pharmacy  
The aim of this study was to develop and validate a simple, sensitive, precise and cost-effective one-level agar diffusion (5+1) bioassay for estimation of potency and bioactivity of Cephalexin in pharmaceutical preparation which has not yet been reported in any pharmacopoeia. Escherichia coli MTCC-443 was selected as the most significant strain against Cephalexin. Bioassay was optimized by investigating several factors such as buffer pH, inoculums concentration and reference standard
more » ... standard concentration. Identification of Cephalexin in commercial sample Cephadex tablet was done by FTIR spectroscopy. Mean potency recovery value for Cephalexin in Cephalexin tablet was estimated as 100.2%. A validated bioassay method showed linearity (r 2 =0.999), precision (Intraday RSD=1.09%, and Interday RSD=0.94%) and accuracy (99.53%, RSD=0.306%). Bioassay was correlated wi th HPLC using same sample and estimated potencies were 100.2% and 99.25%, respectively. Results show that bioassay is a suitable method for estimation of potency and bioactivity of Cephalexin pharmaceutical preparations.
doi:10.7897/2230-8407.08696 fatcat:bddyn7jx2zexpcabfm5ymkxluy