Bioequivalence evaluation of two brands of cefaclor 500 mg capsules: quantification of cefaclor using solid phase extraction technique

Objective: To assess the bioequivalence of two cefaclor 500 mg capsule form ulations, and to develop a new high performance liquid chromatographic (HPL C) method using solid phase extraction technique for the quantification of cefaclor in human plasma. Method: An open, randomized, two-way, cross-over trial with a one-week wash out period in 25 healthy volunteers. The two commercial brands used were Re cocef(R) (Julphar, United Arab Emirates) as test and Ceclor(R) (Eli Lilly, UK) as reference product. The drug was administered with 240 mL of water af ter a 10-h overnight fast. After dosing, serial blood samples were collecte d for a period of 8 h. Plasma harvested from blood was analysed for cefaclo r by a new HPLC method using a solid phase extraction technique. The limit of detection of cefaclor was 17.6 ng/mL; average recovery was 96.5%; the in traday CV was less than 8% and interday CV was less than 13%. Various pharm acokinetic parameters, including AUC (0-t) AUC(0-infinity), C-max, T-max, T -1/2, and K-el, were determined from plasma concentrations for both formula tions. Statistical analysis (ANOVA and 90% confidence intervals) were appli ed to AUC(0-t), AUC(0-infinity) and C-max for bioequivalence evaluation of two brands. The new HPLC method with solid phase extraction circumvented th e problem of mixed polarity of cefaclor and facilitated its extraction from the complex plasma matrix while keeping the background free from interfere nce due to endogenous plasma compounds. Results: No significant difference was observed between the two brands of c efaclor capsules. Conclusion: Recocef(R) was judged bioequivalent to Ceclor,(R) and the two p roducts can therefore be considered to be interchangeable in medical practi ce.