Spectrophotometric Method for Determination of Azelaic Acid: Development and Validation Approach

Abstract

This chapter evaluates to develop accurate, simple, UV spectrophotometric method which is free from extraction techniques, and shorter time and highly sensitive technique. This study describes a simple, accurate, precise and cost effective UV-visible spectrophotometric method for the estimation of Azelaic acid in pure and pharmaceutical formulations. The analytically useful functional groups in Azelaic acid have not been fully exploited for designing suitable, visible spectrophotometric methods and so still offer a scope to develop more visible spectrophotometric methods with better sensitivity, selectivity, precision and accuracy. The method is based on the measurement of absorbance of Azelaic acid solution in Phosphate buffer pH 6.8 at 204nm in the wavelength range of 200-400nm. When using certain media and concentration ranges of 10–50 \(\mu\)g/ml, the procedure complies with Beer’s Lambert’s law. Calculations were also performed for the slope, intercept, and correlation coefficient. The presence of common excipients in tablets did not impair the procedure, according to the results of the percentage recovery investigation. In accordance with the recommendations set forth by the International Conference on Harmonization (ICH), factors such as linearity, precision, accuracy, and sensitivity studies, which includes limit of detection and limit of quantitation, were examined. The proposed method was found to be simple, accurate, precise and rapid for the routine determination of Azelaic acid in pure and pharmaceutical formulation.