Development and Validation Method for Determination of Azithromycin Capsules and Azithromycin for Oral Suspension

Abstract

       The development and validation of reversed phase high performance liquid chromatography (RP-HPLC) method for the determination of azithromycin capsules and azithromycin for oral suspension was established. The separation was achieved on a XTerra C18, 5-μm, 4.6 × 150 mm column, at 50 degree Celsius. The mobile phase was the mixture of acetronitrile, methanol and dibasic potassium phosphate with sodium 1-octanesulfonate pH 8.20 (21:40:39, v/v) at the flow rate of 1.5 ml per minute, setting the detection at 210 nm. Specificity test indicated that azithromycin peak was not interfered by its degradation product peaks from any stress conditions : heat, light, acid/base hydrolysis and oxidation. The described method was linear over the range of 0.1-0.6 mg per ml for azithromycin with correlation coefficient, r, 0.9979. The percentage mean recovery of azithromycin capsules and azithromycin for oral suspension were 99.48 (%RSD = 0.28) and 99.20 (%RSD = 0.61), respectively. The repeatability of azithromycin capsules and azithromycin for oral suspension were performed with %RSD 1.3 and 1.1, respectively. The intermediate precision data (%RSD) obtained among different days, analysts and HPLC instruments of azithromycin capsules and azithromycin for oral suspension were 1.4 and 1.1 respectively. The results showed that this method was robust when HPLC conditions such as the HPLC column, the pH of buffer solution, the ratio of mobile phase, the column temperature and even the flow rate, were changed. The proposed analytical method presented here revealed that it was suitable for the determination of azithromycin capsules and azithromycin for oral suspension. This validated method was further used to analyze azithromycin capsules and azithromycin for oral suspension; it was found that all of the samples complied with the specifications.