title: Stability of ceftazidime in 1% and 5% buffered eye drops determined with HPLC method.
abstract: The aim of the studies was to determine with HPLC method the stability of ceftazidime in buffered 1% and 5% eye drops of proposed formulary composition, which were stored for 30 days at the temperature of 4 degrees C and 20 degrees C and protected from light. The 1% and 5% eye drops were prepared under aseptic conditions by dissolving Biotum (ceftazidimum), dry injection formulation, in citrate buffer of pH 6.10-6.24. The viscosity of the eye drops was increased with polyvinyl alcohol, phenylmercuric borate combined with 2-phenylethanol was used to preserve the eye drops. The eye drops were stored for 30 days in sterile glass bottles at the temperature of 4 degrees C and 20 degrees C and protected from light. The concentration of ceftazidime and pyridine was analyzed simultaneously with HPLC method every three days; pH, osmotic pressure and viscosity were examined as well as the organoleptic analysis of the eye drops (clarity, color, odor). Storage temperature had the biggest impact on ceftazidime stability in the eye drops. The stability of the drops depended also on ceftazidime concentration in the eye drops, the presence of preservatives and polyvinyl alcohol. The time of 10% ceftazidime degradation in buffered 1% and 5% eye drops, stored at the temperature of 4 degrees C, was from 27 to 18 days in 1% eye drops and from 21 to 12 days in 5% eye drops, depending on their composition. In the eye drops which were stored at the temperature of 20 degrees C 10% ceftazidime degradation occurred on the 3rd day of storage in all 1% and 5% formulary versions.
authors.affiliation: Department of Pharmaceutical Technology, Nicolaus Copernicus University, Collegium Medicum in Bydgoszcz, M. Skłodowskiej-Curie 9, Bydgoszcz, Poland. anna.kodym@cm.umk.pl
authors.forename: Anna
authors.initials: A
authors.lastname: Kodym
authors.forename: Dominika
authors.initials: D
authors.lastname: Hapka-Zmich
authors.forename: Marta
authors.initials: M
authors.lastname: Gołab
authors.forename: Magdalena
authors.initials: M
authors.lastname: Gwizdala
mesh_terms: D000900:Anti-Bacterial Agents / Q000737:chemistry*; D002021:Buffers; D002442:Ceftazidime / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D009883:Ophthalmic Solutions; D010626:Phenylethyl Alcohol / Q000737:chemistry; D010663:Phenylmercury Compounds / Q000737:chemistry; D011142:Polyvinyl Alcohol / Q000737:chemistry; D011310:Preservatives, Pharmaceutical / Q000737:chemistry; D011725:Pyridines / Q000737:chemistry; D013678:Technology, Pharmaceutical / Q000379:methods*; D013696:Temperature; D013997:Time Factors; D014783:Viscosity
chemical_list: D000900:Anti-Bacterial Agents; D002021:Buffers; D009883:Ophthalmic Solutions; D010663:Phenylmercury Compounds; D011310:Preservatives, Pharmaceutical; D011725:Pyridines; D011142:Polyvinyl Alcohol; D002442:Ceftazidime; D010626:Phenylethyl Alcohol; C023666:pyridine; C008371:phenylmercury borate