Abstract

The Present work was to develop a simple, fast, accurate, precise, reproducible, Reverse Phase High Performance Liquid Chromatographic Method for simultaneous estimation of Azithromycin and Levofloxacin in pure and combined dosage form marketed as Loxof-AZ. Chromatographic separation was done using Symmetry C18 column having dimension of 4.6×150mm having particle size of 5.0 μm, with mobile phase consisting of Ammonium acetate buffer pH 6 ±0.02 pH and methanol (30:70 %v/v), flow rate was adjusted to 1ml/min and detection wavelength at 262nm. The retention times of Azithromycin and Levofloxacin was found to be 4.862 and 3.515 mins. The proposed method has been validated for accuracy, precision, linearity; robustness and range were within the acceptance limit according to ICH guidelines. Linearity for Azithromycin and Levofloxacin was found in range of 20μg-100μg and 2μg-10μg and correlation coefficient was found to be 0.999 and 0.999% RSD for intermediate precision was found to be 0.1 and 0.2, for repeatability was 0.4 and 0.1, % mean recovery for Azithromycin and Levofloxacin was found to be 99.56% and 99.47% respectively. The method was found to be robust even by change in the mobile phase +10% and in more flow condition. The developed method can be successfully employed for the routine analysis of Azithromycin and Levofloxacin in API and Pharmaceutical dosage forms.

Authors and Affiliations