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KMID : 0941820060160010028
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Korean Journal of Clinical Pharmacy
2006 Volume.16 No. 1 p.28 ~ p.33
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Stability of Cefditoren in Three Oral Liquid Preparations
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Kim Hye-Kyung
Gwak Hye-Sun
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Abstract
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The stability of cefditoren in three kinds of oral liquid preparations at 4 and 25℃ was studied for 90 days. T재 tablets of 100 mg cefditoren pivoxil were mixed with 200 mL of each oral liquid syrup, which is Pebron® syrup (oxolamine citrate10 mg/mL), Mucopect® syrup (ambroxol hydrochloride 3mg/mL) or Tyrenol® suspension (acetaminophen encapsulated 32 mg/mL). Three samples of each formulation were refrigerated (4℃) and three were stored at room temperature (25℃). At predetermined time, samples were assayed by stability-indicating HPLC method. The chromatographic analysis after deliberate degradation showed no evidence of any breakdown product likely to interfere with the chro- matographic peak of the parent substance. The relation between cefditoren pivoxil concentration and peak area was linear from 10 to 150 μg/mL (r2=0.9998). The analysis method was precise, with coefficients of variation no greater than 3.6%. Cefditoren was stable in Mucopect® syrup up to 4 weeks regardless of the temperature; in Tyrenol® suspension and Pebron® syrup, it was stable for at least 28 and 45 days, and 7 and 45 days at 25 and 4℃, respectively. The percentages of initial cefditoren concentration remaining after 90 days were 51.5±1.8 and 80.9±5.6%, 61.7±7.8 and 70.2±7.3%, and 39.9±3.2 and 81.4±5.5% in Mucopect® syrup, Tyrenol® suspension and Pebron® syrup at 25 and 4℃, respectively. The pH variations of all test solutions were minimal, which was within 0.5. The results indicated that the stability of cefditoren was significantly affected by liquid solutions mixed with cefditoren, and storage tempertature.
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KEYWORD
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Cefditoren, Mucopect syrup, Pebron syrup, Tyrenol suspension, Stability
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