Stability of norfloxacin in an extemporaneously prepared oral liquid.
The stability of norfloxacin in an extemporaneously prepared suspension stored at room temperature and under refrigeration was studied over 56 days. A 20-mg/mL suspension was prepared from commercially available 400-mg norfloxacin tablets and equal amounts of Ora-Plus and strawberry syrup to make a final volume of 60 mL. Six identical samples of the suspension were prepared in amber plastic prescription bottles. Three were stored at room temperature (23-25 degrees C) and three under refrigeration (3-5 degrees C). Immediately after preparation and at 7, 14, 28, and 56 days, the samples were assayed in duplicate by stability-indicating high performance liquid chromatography. The samples were also inspected for color and odor changes and the pH of each sample was determined. At least 93% of the 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 degrees C.
Johnson
C E
CE
College of Pharmacy, University of Michigan, 428 Church Street, Ann Arbor, MI 48109-1065, USA. cejohn@umich.edu
Price
J
J
Hession
J M
JM
D000890:Anti-Infective Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding; D004355:Drug Stability; D004356:Drug Storage; D009643:Norfloxacin / Q000032:analysis*; D019999:Pharmaceutical Solutions
D000890:Anti-Infective Agents; D019999:Pharmaceutical Solutions; D009643:Norfloxacin