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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.


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