title: 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.affiliation: Department of Drug Form Technology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń, M. Skłodowskiej-Curie 9, Bydgoszcz, Poland.
authors.forename: Anna
authors.initials: A
authors.lastname: Kodym
authors.forename: Piotr
authors.initials: P
authors.lastname: Bilski
authors.forename: Agata
authors.initials: A
authors.lastname: Domańska
authors.forename: Łukasz
authors.initials: Ł
authors.lastname: Hełminiak
authors.forename: Maria
authors.initials: M
authors.lastname: Jabłońska
authors.forename: Anna
authors.initials: A
authors.lastname: Jachymska
mesh_terms: D060433:Administration, Ophthalmic; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000737:chemistry*; D002021:Buffers; D002437:Cefazolin / Q000008:administration & dosage / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D002951:Citrates / Q000737:chemistry; D003116:Color; D004339:Drug Compounding; D004340:Drug Contamination / Q000517:prevention & control; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D009883:Ophthalmic Solutions; D009997:Osmotic Pressure; D010626:Phenylethyl Alcohol / Q000737:chemistry; D010663:Phenylmercury Compounds / Q000737:chemistry; D011142:Polyvinyl Alcohol / Q000737:chemistry; D011310:Preservatives, Pharmaceutical / Q000737:chemistry; D013211:Staphylococcus aureus / Q000187:drug effects / Q000254:growth & development; D013678:Technology, Pharmaceutical / Q000379:methods*; D013696:Temperature; D013997:Time Factors; D014783:Viscosity
chemical_list: D000900:Anti-Bacterial Agents; D002021:Buffers; D002951:Citrates; D009883:Ophthalmic Solutions; D010663:Phenylmercury Compounds; D011310:Preservatives, Pharmaceutical; D011142:Polyvinyl Alcohol; D002437:Cefazolin; D010626:Phenylethyl Alcohol; C008371:phenylmercury borate