OBJECTIVE: To establish a method for the determination of related substances in Pantoprazole sodium for injections. METHODS: HPLC method was adopted. The determination was performed on Kromasil Hypersil ODS column with mobile phases consisting of 0.01 mol/L potassium dihydrogen phosphate buffer solution (pH adjusted to 7.0)-acetonitrile (gradient elution) at a flow rate of 1.0 mL/min. The detection wavelength was set at 290 nm, and the column temperature was 40 ℃,and injection volume was 20 μL. RESULTS: The linear ranges of impurity A, impurity B, impurity C+E, and impurity D were 0.416 8-1.042 0 μg/mL(r=0.999 8),0.195 0-0.487 5 μg/mL(r=0.999 9),0.389 0-0.972 5 μg/mL(r=0.999 8),0.198 6-0.496 5 μg/mL(r=0.999 8), respectively. The limits of quantitation were 0.834, 0.780, 1.556, 0.794 ng/mL; the limits of detection were 0.417, 0.390, 0.778, 0.397 ng/mL, respectively. RSD of precision test was lower than 1.0%; in repetitive test, RSD for total peak area of impurity was lower than 1.0%; the recoveries were 98.81%-102.49%(RSD=1.18%,n=9),95.31%-98.44%(RSD=0.91%,n=9), 96.88%-98.44%(RSD=0.52%,n=9) and 97.87%-101.28%(RSD=1.05%,n=9). CONCLUSIONS: The method is convenient, accurate and suitable for the determination of related substance in Pantoprazole sodium for injection.
关键词
高效液相色谱法注射用泮托拉唑钠有关物质测定
Keywords
HPLCPantoprazole sodium for injectionRelated substancesDetermination