HPLC法测定肝素钠注射液中6种抑菌剂  

Determination of six antibacterial agents in Heparin Sodium Injection by HPLC

作　　者：由鹏飞 李春焕 陈晓 张迅杰 薛维丽 张乃斌 YOU Pengfei;LI Chunhuan;CHEN Xiao;ZHANG Xunjie;XUE Weili;ZHANG Naibin(Shandong Institute for Food and Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Shandong Research Center of Engineering and Technology for Consistency Evaluation of Generic Drugs,Jinan 250101,China)

机构地区：[1]山东省食品药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,山东省仿制药一致性评价工程技术研究中心,山东济南250101

出　　处：《药学研究》2022年第6期369-372,共4页Journal of Pharmaceutical Research

摘　　要：目的建立高效液相色谱(HPLC)法同时测定肝素钠注射液中苯酚、苯甲醇、三氯叔丁醇、羟苯甲酯、羟苯乙酯、羟苯丙酯6种抑菌剂。方法采用Agilent Zorbax SB-C_(18)(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 mL·min^(-1),检测波长为220 nm及256 nm,柱温30℃。结果苯酚、苯甲醇、羟苯甲酯、羟苯乙酯、三氯叔丁醇、羟苯丙酯分别在25.00~400.06μg·mL^(-1)(r=1.0000)、104.49~1671.88μg·mL^(-1)(r=0.9999)、30.65~490.4μg·mL^(-1)(r=0.9999)、5.36~85.81μg·mL^(-1)(r=0.9999)、49.60~793.54μg·mL^(-1)(r=0.9999)、5.03~80.45μg·mL^(-1)(r=1.0000)内线性关系良好,平均回收率分别为100.3%、99.7%、99.8%、100.0%、99.4%和100.1%,RSD分别为1.0%、1.2%、1.3%、1.4%、1.4%和1.4%(n=9)。结论方法准确,重现性好,结果可靠,可用于肝素钠注射液中6种抑菌剂的测定。Objective To establish a method for determining six antibacterial agents in Heparin Sodium Injection by HPLC.Methods Agilent Zorbax SB-C_(18)(4.6 mm×150 mm,5μm)column was adopted.The mobile phase A was water and the mobile phase B was methanol.The detection wavelength was 220 nm and 256 nm.The flow rate was 1.0 mL·min^(-1)with the column temperature was at 30℃.Results The calibration curve of phenol,benzyl alcohol,methylparaben,ethylparaben,chlorobutanol and propylparaben all showed good linear in range of 25.00~400.06μg·mL^(-1)(r=1.0000),104.49~1671.88μg·mL^(-1)(r=0.9999),30.65~490.4μg·mL^(-1)(r=0.9999),5.36~85.81μg·mL^(-1)(r=0.9999),49.60~793.54μg·mL^(-1)(r=0.9999),5.03~80.45μg·mL^(-1)(r=1.0000).The average recovery rates for phenol,benzyl alcohol,methylparaben,ethylparaben,chlorobutanol and propylparaben were 100.3%,99.7%,99.8%,100.0%,99.4%,100.1%and RSD 1.0%,1.2%,1.3%,1.4%,1.4%,1.4%(n=9).Conclusion The method was accurate,sensitive and simple,and can be used for determination of six antibacterial agents in Heparin Sodium Injection.

关 键 词：高效液相色谱法 肝素钠注射液 抑菌剂 苯酚 苯甲醇 羟苯甲酯 羟苯乙酯 三氯叔丁醇 羟苯丙酯 

分 类 号：R927.2[医药卫生—药学]