Study on Preparation and Quality Standard of Ethacridine Lactate Solution / 中国药房

ABSTRACT

OBJECTIVE: To prepare ethacridine lactate solution and to evaluate its quality.METHODS: The solution was prepared with ethacridine lactate as principal components and sterilized by steam sterilization.HPLC method was used for the determination of ethacridine.Calesil ODS column was used with mobile phase consisted of methanol-acetonitrile-0.05% sodium laurysulfonate (pH=3.0,20 ∶ 20 ∶ 60) at detection wavelength of 270 nm.The column temperature was set at 30 ℃ and injection volume was 10 ?L.The effect of sterilization on the content of preparation was determined.RESULTS: The preparation assumed as yellow transparent solution.The linear range of ethacridine was 5～50 ?g?mL-1(r=0.999 9) with an average recovery of 101.47% (RSD=1.32%,n=9).The content of ethacridine in the solution was not changed after sterilization.CONCLUSION: The quality of prepared ethacridine lactate solution is up to the standard.