Abstract

Maha Abdallah Alnuwaiser^*

DOI : http://dx.doi.org/10.13005/ojc/370215

Azithromycin is a board antibiotic that affects various gram-positive and negative bacteria, so azithromycin is used for the treatment different of bacterial infections, as well as used azithromycin as a prophylactics antibiotic after different surgery. Azithromycin is used for children and adults, so it is available in pharmacies in different dosage forms like capsules, tablets, powder for reconstituting for oral administration. The aims of the present research is to assess the azithromycin stability from different available dosage forms (bioequivalence study) against temperature in hot climate country (Saudi Arabi). Three samples in the form of three drugs in which Azithromycin acts as an active ingredient were prepared and exposed to heat. These drugs are Azithromycin® 250 mg, Az-1® 250 mg,andZirox® 250 mg. Three spectral techniques were used to study the change in concentration and chemical composition when the temperature is raised from 27Co to 60Co the spectrometers used are ultraviolet spectrometer and Gas Chromatography-Mass Spectrometry. The temperature of the three drugs was raised from 27Co to 60Co inside the water path. The ultraviolet spectrometer shows considerable degradation in Azithromycin concentration by raised the temperature from 27Co to 60Co, but the other two drugs are not affected appreciably by heating.The results obtained using the retention time technique of gas chromatography, show a change of the retention time to be (20.308- 20.396 -20.350) for Azithromycin®, Az-1®, and Zirox®scanned, respectively. This change may result from the difference in the matrix chemical composition of each drug. The mass spectrometry results show that rising temperature to 60Co district the chemical bond of the active ingredient to be decomposed to five compounds having M/Z (43-72-99-158-198), respectively.

Azithromycin; Bioequivalence Study; Chemical Stability; Gas Chromatography-Mass Spectrometer; Temperature Degradation

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