钱莉芬.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[J].中国药品标准,2023,24(1): |
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 |
投稿时间:2022-04-29 修订日期:2023-01-31 |
DOI: |
中文关键词: 复方硫酸软骨素片 硫酸软骨素 甘草酸 梯度洗脱 波长切换 |
英文关键词: Compound Chondroitin Sulfate Tablets chondroitin sulfate glycyrrhizic acid gradient elution wavelength switching |
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中文摘要: |
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 C18色谱柱(4.6 mm × 250 mm,5 μm),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。 |
英文摘要: |
Abstract Objective: To establish an HPLC gradient elution - wavelength switching method for Simultaneous determination of chondroitin sulfate and glycyrrhizic acid in Compound Chondroitin Sulfate Tablets. Methods: The chromatographic separation was performed on InertSustain C18 column (4.6mm×250 mm,5μm),and gradient elution was conducted with 5mmol·L-1 Sodium heptane sulfonate solution as mobile phase A and acetonitrile as mobile phase B. The column temperature was set at 35℃, and the detection wavelength was chosen at 199nm for chondroitin sulfate during 0-8min, 251nm for glycyrrhizic acid during 8-30min. Results: The linear ranges of chondroitin sulfate and glycyrrhizic acid were 0.1502-3.0049mg·mL-1 and 0.01267-0.3168mg·mL-1, respectively. The specificity, precision and recovery etc. of the method was good. The content ranges of chondroitin sulfate and glycyrrhizic acid in four batches of samples were 72.1963-73.8014 and 1.4988-1.5480mg per tablet, respectively. Conclusion: The method is simple, accurate, and suitable to be used for the quality control of Compound Chondroitin Sulfate Tablets. |
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