Content Determination of Acetic Acid in Octreotide Acetate for Injection by IEC / 中国药房

ABSTRACT

OBJECTIVE:To determine the content of acetic acid in Octreotide acetate for injection by IEC,and provide reference for the improvement of pharmacopoeia standards. METHODS:The column was Rezex ROA-Organic Acid H+ with mobile phase of 0.002 5 mol/L sulfuric acid at a flow rate of 0.5 ml/min,the detection wavelength was 210 nm,column temperature was 45℃,and in-jection volume was 100 μl. RESULTS:The linear range of acetic acid was 0.394 4 μg/ml-78.89 μg/ml(r=0.999 9);RSDs of preci-sion,stability and reproducibility tests were all lower than 2%;the limit of quantification was 197.2 ng/ml,and limit of detection was 78.89 ng/ml;recovery was 104.71%-109.78%(RSD=1.34%,n=9). CONCLUSIONS:The method is environmental and simple with good accuracy and precision,and suitable for the content determination of acetic acid in Octreotide acetate for injection.