title: Stability studies of lincomycin hydrochloride in aqueous solution and intravenous infusion fluids.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the chemical stability of Lincocin(®) (lincomycin hydrochloride) in commonly used intravenous fluids at room temperature (25°C), at accelerated-degradation temperatures and in selected buffer solutions.
  
  
  METHODS
  The stability of Lincocin(®) injection (containing lincomycin 600 mg/2 mL as the hydrochloride) stored at 25°C±0.1°C in sodium lactate (Hartmann's), 0.9% sodium chloride, 5% glucose, and 10% glucose solutions was investigated over 31 days. Forced degradation of Lincocin(®) in hydrochloric acid, sodium hydroxide, and hydrogen peroxide was performed at 60°C. The effect of pH on the degradation rate of lincomycin hydrochloride stored at 80°C was determined.
  
  
  RESULTS
  Lincomycin hydrochloride w as found to maintain its shelf life at 25°C in sodium lactate (Hartmann's) solution, 0.9% sodium chloride solution, 5% glucose solution, and 10% glucose solution, with less than 5% lincomycin degradation occurring in all intravenous solutions over a 31-day period. Lincomycin hydrochloride showed less rapid degradation at 60°C in acid than in basic solution, but degraded rapidly in hydrogen peroxide. At all pH values tested, lincomycin followed first-order kinetics. It had the greatest stability near pH 4 when stored at 80°C (calculated shelf life of 4.59 days), and was least stable at pH 2 (calculated shelf life of 0.38 days).
  
  
  CONCLUSIONS
  Lincocin(®) injection was chemically found to have a shelf life of at least 31 days at 25°C when added to sodium lactate (Hartmann's) solution, 0.9% sodium chloride solution, 5% glucose solution, and 10% glucose solution. Solutions prepared at approximately pH 4 are likely to have optimum stability.
authors.affiliation: School of Pharmacy, Curtin University, Perth, WA, Australia.
authors.forename: Petra
authors.initials: P
authors.lastname: Czarniak
authors.affiliation: School of Pharmacy, Curtin University, Perth, WA, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Boddy
authors.affiliation: School of Pharmacy, Curtin University, Perth, WA, Australia.
authors.forename: Bruce
authors.initials: B
authors.lastname: Sunderland
authors.affiliation: School of Pharmacy, Curtin University, Perth, WA, Australia.
authors.forename: Jeff D
authors.initials: JD
authors.lastname: Hughes
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007262:Infusions, Intravenous; D008034:Lincomycin / Q000737:chemistry*; D012996:Solutions; D013696:Temperature; D014867:Water / Q000737:chemistry*
chemical_list: D012996:Solutions; D014867:Water; D008034:Lincomycin
keywords: IV additives; intravenous fluids; lincomycin; pH; stability