HPLC法同时测定复方硫酸软骨素片中硫酸软骨素和甘草酸含量的研究  

Simultaneous determination of chondroitin sulfate and glycyrrhizic acid in compound chondroitin sulfate tablets by HPLC

作　　者：钱莉芬 解瑞辉 杨坤 张海娜 QIAN Lifen;XIE Ruihui;YANG Kun;ZHANG Haina(Puyang Food and Drug Inspection and Testing Center,Puyang 475000,China)

机构地区：[1]濮阳市食品药品检验检测中心,河南濮阳475000

出　　处：《中国药品标准》2023年第1期61-65,共5页Drug Standards of China

摘　　要：目的:建立高效液相色谱梯度洗脱-波长切换法同时测定复方硫酸软骨素片中硫酸软骨素和甘草酸含量的方法。方法:采用InertSustain C 18色谱柱(4.6 mm×250 mm,5μm),以5 mmol·L^(-1)庚烷磺酸钠溶液为流动相A,乙腈为流动相B,梯度洗脱,柱温为35℃,检测波长为199 nm(0~8 min时,检测硫酸软骨素)、251 nm(8~30 min时,检测甘草酸)。结果:硫酸软骨素钠和甘草酸分别在0.1502~3.0049 mg·mL^(-1)和0.01267~0.3168 mg·mL^(-1)范围内与峰面积呈良好的线性关系,且该检测方法专属性、精密度、回收率等良好。4批样品中,硫酸软骨素和甘草酸的含量分别为72.1963~73.8014和1.4988~1.5480 mg·片-1。结论:该方法操作简单,结果准确,可用于复方硫酸软骨素片的质量控制。Objective:Establishment of a high-performance liquid chromatography gradient elution-wavelength switching method for the simultaneous determination of chondroitin sulfate and glycyrrhizic acid in compound chondroitin sulfate tablets.Methods:An InertSustain C 18 column(4.6 mm×250 mm,5μm)was used,with 5 mmol·L^(-1) sodium heptanesulfonate solution as mobile phase A,acetonitrile as mobile phase B,gradient elution,and the column temperature was 35℃.Detection wavelengths were 199 nm(0-8 min,chondroitin sulfate),251 nm(8-30 min,glycyrrhizic acid).Results:Chondroitin sulfate sodium and glycyrrhizic acid showed a good linear relationship with the peak area in the range of 0.1502-3.0049 mg·mL^(-1) and 0.01267-0.3168 mg·mL^(-1),respectively,and the detection method was specific,precision,recovery rate,etc.good.In the 4 batches of samples,the contents of chondroitin sulfate and glycyrrhizic acid were 72.1963-73.8014 and 1.4988-1.5480 mg·tablet-1.Conclusion:The method is simple and accurate,and can be used for the quality control of compound chondroitin sulfate tablets.

关 键 词：复方硫酸软骨素片 硫酸软骨素 甘草酸 梯度洗脱 波长切换 

分 类 号：R921.2[医药卫生—药学]