HPLC法检测醋酸奥曲肽注射剂中5种抑菌剂  

HPLC Determination of Five Antibacterial Agents in Octreotide Acetate Injection

作　　者：李茜[1] 刘英[1] Li Qian Liu Ying(Henan Provincial Institute of Food and Drug Control, Zhengzhou 450003, Chin)

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国药事》2017年第1期60-68,共9页Chinese Pharmaceutical Affairs

摘　　要：目的:检测醋酸奥曲肽注射剂中是否添加苯酚、苯甲醇、三氯叔丁醇、对羟基苯甲酸甲酯及对羟基苯甲酸丙酯5种抑菌剂。方法:采用C18(L)(4.6 mm×250 mm,5μm)色谱柱,流动相A为水,流动相B为甲醇,梯度洗脱,流速为1.0 m L·min^(-1),柱温30℃,检测波长为220 nm及256 nm。结果:苯酚、苯甲醇、三氯叔丁醇、对羟基苯甲酸甲酯及对羟基苯甲酸丙酯各峰均分离良好;苯酚在1.29~258.60μg·m L^(-1)范围内线性关系良好(r=1.000),平均回收率为100.0%(n=9);苯甲醇在2.72~544.20μg·m L^(-1)范围内线性关系良好(r=0.9997),平均回收率为100.3%(n=9);三氯叔丁醇在9.95~1990.00μg·m L^(-1)范围内线性关系良好(r=1.000),平均回收率为100.9%(n=9);对羟基苯甲酸甲酯在0.27~53.80μg·m L^(-1)范围内线性关系良好(r=1.000),平均回收率为100.5%(n=9);对羟基苯甲酸丙酯在0.26~52.00μg·m L^(-1)范围内线性关系良好(r=1.000),平均回收率为99.4%(n=9);91批醋酸奥曲肽注射剂中均未检出5种抑菌剂。结论:该方法准确、灵敏、简便,可用于醋酸奥曲肽注射剂中苯酚、苯甲醇、三氯叔丁醇、对羟基苯甲酸甲酯及对羟基苯甲酸丙酯5种抑菌剂的检查。Objective： To detect whether the octreotide acetate injection was added with the five antibacterial agents of phenol, benzyl alcohol, chlorobutanol, methyl p-hydroxybenzoate and propyl p-hydroxybenzoate. Methods： An Agela Venusuil ASB C18 （L） （4.6 mm×250 mm, 5 μm） column was adopted. The mobile phase A was water and the mobile phase B was methanol, the flow rate was 1.0 mL·min^-1, the column temperature was 30℃, and the detection wavelength was 220 nm and 256 nm. Results： The five kinds of antibacterial agents were well separated. The linear range of phoenol was 1.29-258.60 μg·mL^-1, and the average recovery was 100.0%（n=9）. The linear range of benzyl alcohol was 2.72-544.20 μg·mL^-1, and the average recovery was 100.3%（n=9）. The linear range of chlorobutanol was 9.95-1990.00 μg·mL^-1, and the average recovery was 100.9%（n=9）. The linear range of methyl p-hydroxybenzoate was 0.27-53.80 μg - mL^-1, and the average recovery was 100.5%（n=9）. The linear range of propyl p-hydroxybenzoate was 0.26-52.00 μg·mL^-1, and the average recovery was 99.4% （n=9）. None of the five kinds of antibacterial agents were detected in the 91 batches of octreotide acetate injection. Conclusion： The method is accurate, sensitive and simple, and can be used for determination of phenol, benzyl alcohol, chlorobutanol, methyl p-hydroxybenzoate and propyl p-hydroxybenzoate in octreotide acetate injection.

关 键 词：醋酸奥曲肽 醋酸奥曲肽注射液 注射用醋酸奥曲肽 抑菌剂 苯酚 苯甲醇 三氯叔丁醇 对羟基苯甲酸甲酯 对羟基苯甲酸丙酯 

分 类 号：R927.2[医药卫生—药学]