Development and Validation of Simple UV Spectrophoto-metric Method for Estimation of Azithromycin in Dosage Form using Hydrotropic Solubilization Technique
DOI:
https://doi.org/10.37285/ijpsn.2023.16.6.5Abstract
Objective: A new UV method was developed for the estimation of azithromycin in tablets using the hydrotropic solubilization method and it was validated as per ICH guidelines.
Methods: The solubility of azithromycin was studied in various hydrotropic agents and the one with the best solubility was considered as solvent for developing and validating the UV spectrophotometric method.
Results: The best solubility of azithromycin was witnessed in a 2M sodium acetate solution in water. The absorption maximum of azithromycin in 2M sodium acetate was found to be 221 nm. The method was found to be linear in the range of 10-50µg/ml. The precision of the method was good and the recovery of drugs was well within the acceptance limits of 80-120%.
Conclusion: The proposed UV method was found suitable for the estimation of azithromycin in formulations and is simple, selective, reproducible, and accurate with good precision, and can be successfully applied to routine analytical purposes.
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Keywords:
Azithromycin, estimation, UV-Visible spectroscopy, hydrotropy, ICH, validationPublished
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References
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