高效液相色谱法测定鲑鱼降钙素鼻喷剂中苯扎氯铵的含量  

Determination of benzalkonium chloride in salmon calcitonin nasal spray by HPLC

作　　者：周朝东 黄哲甦 Zhou Chaodong;Huang Zhesu(Tianjin Institute for Drug Control,Tianjin 300070)

机构地区：[1]天津市药品检验研究院,天津300070

出　　处：《天津药学》2018年第5期1-4,共4页Tianjin Pharmacy

摘　　要：目的:建立用高效液相色谱法测定鲑鱼降钙素鼻喷剂中防腐剂苯扎氯铵含量的方法。方法:采用高效液相色谱法。色谱柱为watersμBondpak~ CN 125色谱柱(150 mm×3. 9 mm,10μm),流动相为乙腈-水-四甲基氢氧化铵(475 ml∶525 ml∶1. 99 g,磷酸调节p H值至2. 5),流速为0. 6 ml/min,柱温为40℃,紫外检测器,检测波长为210 nm,进样量为50μl。结果:苯扎氯铵浓度在45. 525 2～136. 575 6μ36g/ml范围内,其浓度与峰面积呈良好线性关系(r=1. 0000);平均回收率为99. 4%,RSD为0. 69%(n=9);检出限为0. 4 ng,定量限为1. 4 ng;精密度、稳定性试验的RSD <1. 0%。结论:该方法操作简单、结果准确、专属性强,可用于鲑鱼降钙素鼻喷剂中防腐剂苯扎氯铵的含量测定。Objective:A high performance liquid chromatographic(HPLC)method was established for the determination of benzalkonium chloride in salmon calcitonin nasal spray.Methods:The chromatographic conditions were as follows:watersμBondpak■CN,10μm,125 Column(150 mm×3.9 mm,5μm)with the column temperature at 40℃;acetonitrile-water-tetramethylammonium hydroxide(475 ml∶525 ml∶1.99 g,using phosphoric acid to adjust pH to 2.5)as mobile phase with flow rate of 0.6 ml/min.Benzalkonium chloride was detected by UV detector at wavelength of 210 nm.The injection volume was 50μl.Results:The linear range of benzalkonium chloride was 45.525 2~136.575 6μg/ml(n=5),the average recovery rate was 99.4%(RSD was 0.69%,n=9),the limit of detection(LOD)was 0.4 ng and the limit of quantification(LOQ)was 1.4 ng.RSD values for both precision and stability test were lower than 1.0%.Conclusion:The method is simple,accurate and strongly specific,which is suitable for the content determination of benzalkonium chloride in salmon calcitonin nasal spray.

关 键 词：高效液相色谱法 鲑鱼降钙素鼻喷剂 苯扎氯铵 含量测定 

分 类 号：R927.2[医药卫生—药学]