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Author: Admin | 2025-04-28
All commercially available Azithromycin tablet formulations that were under investigation. The chromatographic system for azithromycin working standard, and samples were displayed under Table 2.Chromatographic systems. Procedure: An equal volume of about Azithromycin working standard, and the Assay preparation are separately injected into the chromatograph, and the peak area of the responses are measured for all the peaks and compared with USP36/NF31 acceptance limit (% label claim of 90%-110%) Eq (3).(3)Where,Ru = is the peak response of azithromycin Sample solution, Rs = is peak response of the Azithromycin working standard, Cs = is the concentration of USP Azithromycin working standard (mg.ml), Cu = is the concentration of the sample solution (mg/ml), p = is the potency of USP azithromycin working standard,(μg/mg), and F = is conversion factor (0. 001mg/μg)Construction of calibration curve. The concentration of Azithromycin working standard was prepared by dissolving 20mg of working standard into 50 ml volumetric flask. Then, up to the mark, diluent A was added to generate a solution with a known concentration of around 400μg/ml. From this, standard solutions containing about 320, 360, 400, 440, and 480μg/ml were made at a concentration range of 80%-120% as per Food, and Drug Administration office of Regulatory affairs guideline [35]. Then, a volume of around 50 μl was injected into the HPLC. Then, their respective Areas under the Curve (AUC) were recorded. The calibration curve was then determined by plotting the concentration of Azithromycin working standard vs. peak area. The equation for the calibration curve of the Azithromycin
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