Development and Validation of a Spectrophotometric Method for Quantification of Clarithromycin Tablets

Abstract

We describe a spectrophotometric method for quantification of clarithromycin tablets, which is based on the formation of a colored chromophore compound resulting from the reaction between clarithromycin solution with concentrated sulfuric acid, this chromophore absorbs at 481 nm. At this wavelength the clarithromycin-containing chromophore presents an absorbance that is directly related to its concentration. The evaluation of the traceability of the results obtained with the spectrophotometric method was performed by comparison with the reference method (HPLC Chromatography USP 29) and statistically through a paired t test, which determined that there were no significant differences between the results of both methods indicating that
the developed method is traceable. Finally, the spectrophotometric method was validated to ensure consistency and reproducibility of the results. The evaluated parameters were specificity, robustness, linearity, accuracy, precision expressed in two ways: Repeatability and reproducibility. The analytical method proved to be specific for Clarithromycin, and linear in the range of 15-50 ppm. The variation coefficient obtained for repeatability and reproducibility was 1% and the percentage of recovery obtained was 100.5%.