Stability of Ciprofloxacin in Extemporaneous Oral Liquid Dosage Form
Author(s): Johnson Cary E, Wong Douglas V, Hoppe Heather L, Bhatt-Mehta Varsha
Issue: Jul/Aug 1998 - Dermatology
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Abstract: The stability of ciprofloxacin hydrochloride in an extemporaneously compounded oral liquid formulation was studied. A suspension was prepared by mixing four crushed, commercially available 750-mg tablets of ciprofloxacin hydrochloride with equal amounts of Ora Plus™ and simple syrup, NF to make a final volume of 60 mL. The final concentration of ciprofloxacin hydrochloride in the suspension was 50 mg/mL. Six identical suspensions were prepared, placed in amber, plastic prescription bottles and stored at room temperature (24 to 26°C) and under refrigeration (3 to 5°C). Immediately after preparation and at seven, 14, 28 and 56 days, samples were removed and assayed in duplicate by stability-indicating high-performance liquid chromatography. Color, odor and pH did not change appreciably over the study period. At least 99% of the initial ciprofloxacin hydrochloride concentration remained in all suspensions throughout the study period. Ciprofloxacin hydrochloride 50 mg/mL compounded extemporaneously in equal amounts of Ora Plus and simple syrup, NF was stable at room temperature and under refrigeration for at least 56 days in amber, plastic prescription bottles.
Related Categories: GERIATRICS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES
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