Contents Determination of Citric Acid in Fentanyl Citrate Raw Materials and Its Injection by Ion Chroma-tography / 中国药房

ABSTRACT

OBJECTIVE:To determine the contents of citric acid in fentanyl citrate raw materials and its injection by ion chro-matography. METHODS:The determination was performed on Thermo Dionex IonPacTM AS11-HC column with mobile phase con-sisted of potassium hydroxide (gradient elution) at the flow rate of 1.0 mL/min. The column temperature was 35 ℃,and sample size was 20 μL. The detector was suppressed conductivity detector. RESULTS:The linear range of citric acid were 0.1157-74.05 μg/mL(r=0.9995). The limit of quantitation was 0.1150 μg/mL,and the limit of detection was 0.0400 μg/mL;RSDs of preci-sion,stability and reproducibility tests were all lower than 2.0%;the average recoveries were 99.6%-101.5%(RSD=0.68%,n=9). CONCLUSIONS:The method is environmentally-friendly and simple with good accuracy and precision,and suitable for the contents determination of citric acid in fentanyl citrate raw materials and injection.