Development and validation of high-performance liquid chromatography method for determination of clarithromycin in pharmaceutical tablets

Clarithromycin is a very important macrolide antibiotic used to treat bacterial infections in human and veterinary medicine. This study reports the development and validation of cost-effective, simple, precise, accurate, and robust high-performance liquid chromatography (HPLC) for the determination of clarithromycin (CLA) in tablets. Reversed-phase chromatography was conducted using a standard column at 55(?)C with ultraviolet detection at 215 nm. A mobile phase consisting of acetonitrile -2-methyl-2-propanol -potassium phosphate buffer was used at a flow rate of 1.0 mL/min. The proposed method displayed good linearity, precision, accuracy, robustness, and specificity. The present HPLC was compared with capillary electrophoresis and bioassay methods and the results indicated that there was no significant difference between these methods. Moreover, the obtained results demonstrated the validity of the isocratic HPLC, which allows reliable quantitation of CLA in pharmaceutical samples. Thus, it can be used as a substitute alternative methodology for the routine quality con-trol of this medicine, in situations where other methods are less accessible in the laboratory.

Automated summary

This study developed and validated a cost-effective and reliable HPLC method for quantifying clarithromycin in tablets. The proposed method showed good linearity, precision, accuracy, robustness, and specificity, and was comparable to capillary electrophoresis and bioassay methods. Therefore, it can be used as an alternative method for routine quality control of clarithromycin, especially when other methods are not accessible.