The stability of norfloxacin in an extemporaneously prepared suspension sto
red at room temperature and under refrigeration was studied over 56 days.
A 20-mg/mL suspension was prepared from commercially available 400-mg norfl
oxacin tablets and equal amounts of Ora-Plus and strawberry syrup to make a
final volume of 60 mt. Six identical samples of the suspension were prepar
ed in amber plastic prescription bottles. Three were stored at room tempera
ture (23-25 degreesC) and three under refrigeration (3-5 degreesC). Immedia
tely after preparation and at 7, 14,28, and 56 days, the samples were assay
ed in duplicate by stabilily-indicating high performance liquid chromatogra
phy. The samples were also inspected for color and odor changes and the pH
of each sample was determined.
At least 93% of tile initial norfloxacin concentration remained throughout
the 56-day study period. The color, odor, and pH of all of the samples did
not change appreciably.
An extemporaneously prepared suspension of norfloxacin 20 mg/mL was stable
for at least 56 days when stored at either 23-25 or 3-5 degreesC.