Stress degradation studyTo determine whether the developed analytical method was stability indicating, Erythromycin estolate standard solution was stressed under various conditions includesOxidative degradation:Erythromycin estolate solution was prepared in 3% hydrogen peroxide and kept in a mechanical shaker at at50°C for 1 hour to facilitate the oxidation of the drug.
Acid hydrolysis:Erythromycin estolate solution was prepared in 0.01N hydrochloric acid and kept in a mechanical shaker at 50°C for 15 min Alkaline hydrolysis:Erythromycin estolate Solutions were prepared in 0.01 N sodium hydroxide and kept at roomThe temperature for I hour.
Temperature stress studies:Erythromycin 250mg capsules were exposed to dry heat (105°C) in a hot air oven for 2 h, 42min. The drug solution was prepared and subjected to analysis. Photostability studies: Erythromycin 250mg capsules were exposed to light to reach greater than 1.
2 million LuxHours. The drug solution was prepared and subjected to analysisThermal/Humidity studies:Placebo, Erythromycin 250mg capsules is subjected directly at 50°C/75% RH for 7days. The samples were analyzed.
The optimized method was validated as per International Conference on Harmonization (ICH) guidelines for validation of analytical procedures. The validated parameters were system suitability, specificity, and linearity, accuracy, precision, and robustness.