厄贝沙坦氢氯噻嗪片相关检查及含量测定  

Related Inspections and Content Determination of Irbesartan and Hydrochlorothiazide Tablets

作　　者：李梓莹 LI Zi-ying(Guangzhou Institute for Drug Control,Guangzhou,Guangdong 510160,China)

机构地区：[1]广州市药品检验所,广东广州510160

出　　处：《湖北医药学院学报》2025年第1期75-79,83,共6页Journal of Hubei University of Medicine

摘　　要：目的:建立高效液相色谱方法对厄贝沙坦氢氯噻嗪片进行4-氨基-6-氯-1,3-苯二磺酰胺及氢氯噻嗪含量均匀度检查并同时测定氢氯噻嗪与厄贝沙坦的含量。方法:采用C18色谱柱,以0.1 mol/L磷酸二氢钠为流动相A,乙腈为流动相B进行梯度洗脱,检测波长为224 nm,4-氨基-6-氯-1,3-苯二磺酰胺检查进样20μL,含量均匀度检查及含量测定进样10μL。结果:4-氨基-6-氯-1,3-苯二磺酰胺在0.14335~2.8670μg/mL范围内线性关系良好。氢氯噻嗪在0.97706~19.541μg/mL范围内线性关系良好,厄贝沙坦在12.56~251.2μg/mL范围内线性关系良好,供试品溶液在15 h内稳定。结论:本法简单,灵敏、准确,重现性好,在进行4-氨基-6-氯-1,3-苯二磺酰胺及氢氯噻嗪含量均匀度检查的同时还能测定氢氯噻嗪与厄贝沙坦的含量。Objective To develop a high-performance liquid chromatography(HPLC)method for determining the content uniformity of 4-amino-6-chloro-1,3-benzenedisulfonamide and hydrochlorothiazide,as well as the content of irbesartan and hydrochlorothiazide.Methods The determination was performed using a C18 chromatographic column,with 0.1 mol/L sodium dihydrogen phosphate as mobile phase A and acetonitrile as mobile phase B in a gradient elution.The detection wavelength was set at 224 nm.A sample injection volume of 20μL was used for 4-amino-6-chloro-1,3-benzenedisulfon⁃amide analysis,while a volume of 10μL was used for content uniformity inspection and content determination.Results There was a good linear relationship for 4-amino-6-chloro-1,3-benzenedisulfonamide in the concentration range of 0.14335 to 2.8670μg/mL.Hydrochlorothiazide and irbesartan showed good linear relationships in the concentration range of 0.97706 to 19.541μg/mL and 12.56 to 251.2μg/mL,respectively.The test solution remained stable for 15 h.Conclu⁃sion This method is simple,sensitive,and accurate,with good reproduciblity.It can simultaneously determine the content uniformity of 4-amino-6-chloro-1,3-benzenedisulfonamide and hydrochlorothiazide and the content of hydrochlorothiazide and irbesartan.

关 键 词：厄贝沙坦氢氯噻嗪片 含量测定 4-氨基-6-氯-1 3-苯二磺酰胺 

分 类 号：R927.2[医药卫生—药学]