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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.

Authors

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

Institution

Department of Drug Form Technology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń, M. Skłodowskiej-Curie 9, Bydgoszcz, Poland.

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