Abstract
A simple, sensitive and robust HPLC-UV method was developed for bioequivalence of two azithromycin tablets (zetro and azomax). The chromatographic separation was attained on Shim-Pak ODS 5 mu m (4.6 x 250 mm) column in isocratic mode using methanol and acetonitrile (30: 70) at 1 mL/min flow rate and pH 3.2 followed by UV detection at 220 nm. A single dose, equivalent to 500 mg dose as per average human body weight of both test products were administered to healthy rabbits. Pharmacokinetic parameters were calculated from the plasma concentration curves of both formulations. The limit of detection and limit of quantification of the drug were found to be 0.012 and 0.104 mg/mL in mobile phase and 0.0239 and 0.2072 mg/mL in animal plasma, respectively. Pharmacokinetic analysis of the data showed that the two formulations were bioequivalent. In addition, the method developed has been found suitable for the routine quality control tests.