Bioanalysis and in-vivo studies of clarithromycin modified release solid dosage formulations by liquid chromatography-mass spectroscopy

Abstract

The current study was undertaken to develop the new bioanalytical method and validation for determining Clarithromycin by LC-MS Method and as well as to conduct in vivo studies. Princeton octadecyl silane column (10 cm x 4.6 mm id, 5µm) used as adsorbent and cyanomethane: 0.5 % Methanoic acid was treated as the eluent for the separation of the analyte from the biological fluid in an isocratic mode having the ratio 60:40 % v/v and 0.5 ml/min as flow rate, and injection volume was set as 20 µl. APCI and the mass detected of Clarithromycin and Azithromycin (act as internal standard) was detected at 748.45 and 749.70, respectively. Developed bioanalytical methods have been used to quantify the Pharmacokinetic parameters like Cmax, Tmax, AUC0_-t & AUC0_-∞, Keli, and t_1/2  studied and the values for reference formulation (3.382µg/ml, 7.333 h, 114.429µg.h/ml, 131.435µg.h/ml, 0.031 h^-1, and 23.397h respectively) and the test formulation (3.847 µg/ml, 7.417 h, 132.318 µg.h/ml, 151.388 µg.h/ml, 0.031 h^-1, and 23.187 h, respectively) were compared and found to be bioequivalent. Based on our study, the test formulation of Clarithromycin modified-release formulation containing 500 mg of Clarithromycin is Bioequivalent to that of the reference. Compare to our method (LC-MS) is simple, sensitive, precise as well as comparable with the reference formulation of the modified release product of clarithromycin 500 mg.