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Physical and chemical properties and stability of sodium cefazolin in buffered eye drops determined with HPLC method.

Abstract

The aim of the studies was to analyze the stability of 1% and 5% eye drops containing sodium cefazolin, prepared in citrate buffer of pH 6.11-6.27, which were stored at the temperature of 4 degrees C and 20 degrees C with light protection. The drops were prepared under aseptic conditions by dissolving sodium cefazolin (Biofazolin, IBA Bioton), dry injection form of the drug, in citrate buffer. The viscosity of the drops was increased using polyvinyl alcohol. The drops were preserved with phenylmercuric borate of 0.001% concentration mixed with beta-phenylethyl alcohol of 0.4% concentration in the drops. The concentration of cefazolin was determined at every three days using HPLC method. Besides, the measurements of pH, osmotic pressure and viscosity were performed as well as the organoleptic analysis of the drops (clarity, color, odor). The concentration of cefazolin in 1% drops after the 30-day-storage at the temperature of 4 degrees C, depending on their composition, decreased in the range of 2.17-6.02%. In 5% drops the decrease in cefazolin concentration was similar, i.e., after 30-day-storage at the temperature of 4 degrees C it was 1.62-6.76%. In 1% and 5% drops stored at the temperature of 20 degrees C the stability of the drops determined as the 10% degradation time of cefazolin was in the range of 9-15 days.

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  • Authors

    Kodym A, Bilski P, Domańska A, Hełminiak Ł, Jabłońska M, Jachymska A

    Source

    Acta poloniae pharmaceutica 69:1 pg 95-105

    MeSH

    Administration, Ophthalmic
    Anti-Bacterial Agents
    Buffers
    Cefazolin
    Chemistry, Pharmaceutical
    Chromatography, High Pressure Liquid
    Citrates
    Color
    Drug Compounding
    Drug Contamination
    Drug Stability
    Hydrogen-Ion Concentration
    Ophthalmic Solutions
    Osmotic Pressure
    Phenylethyl Alcohol
    Phenylmercury Compounds
    Polyvinyl Alcohol
    Preservatives, Pharmaceutical
    Staphylococcus aureus
    Technology, Pharmaceutical
    Temperature
    Time Factors
    Viscosity

    Pub Type(s)

    Journal Article
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    22574512