The photostability study of gatifloxacin under stressed conditions

Abstract EN

-The photo stability of gatifloxacin, (an 8-methoxy fluoroquinolone antibacterial agent), as a raw material in both solution form as well as in tablet formulations was studied applying the International Conference on Harmonization (ICH) conditions.

In addition, the effect of packaging of this dosage form on the photo stability of the drug was determined.

The light irradiation was performed using a solar simulator of Xenon lamp within a wavelength range 250-400 nm.

Samples were irradiated with two light doses for a period of 90 minutes.

Dose I was 3 W/m2 / h visible light, 50 W/m2 /h UVA, and 2.9 W/m2 /h UVB; and Dose II was 6.5 W/m2/h visible light, and 150 W/m2 /h UVA, and 12.38 W/m2 /h UVB.

The photo degradation process was monitored by UV spectrophotometry and Fourier transformer Infra-Red.

All of the prepared tablets unpackaged and in blister, together with the commercially available Sequin (Bristol-Myers Squibb) tablets in blister sheet (marketing pack), and gatifloxacin in solution showed neither discoloration nor change in appearance when exposed to the used dose I of light.

On the contrary, exposing gatifloxacin powder to the dose II of light caused color change.

A negligible degradation of gatifloxacin was noted for the drug in raw material (powder) irradiated with Dose II where 97.94% gatifloxacin remaining, while gatifloxacin solution (salt) was relatively more affected with 92.7 % gatifloxacin remaining after 90 minutes exposure to dose II.

The percentage of gatifloxacin remaining after 90 minutes exposure of unpackaged tablets to dose I and dose II were acceptable where 99.1 and 98.34 % drug remaining respectively.

However, there was 2.65 % degradation of gatifloxacin in sequin tablets in blister packaging after 90 minutes exposure to dose II of light, while the prepared tablet showed no degradation after 90 minutes exposure to the same dose.

Finally, it could be concluded that the prepared tablets were photos table on stressed conditions and it was dependent on excipients used in the formulation of tablets and the presence of packaging.