| 李霞,杨鑫,易徐航,杨恢检,肖小武.HPLC法同时测定益气养血口服液中6种防腐剂含量[J].,2025,34(8):59-64 |
| HPLC法同时测定益气养血口服液中6种防腐剂含量 |
| Simultaneous Determination of Six Preservatives in Yiqi Yangxue Oral Liquid by HPLC |
| 投稿时间：2024-07-26 |
| DOI： |
| 中文关键词: 益气养血口服液 防腐剂 含量测定 HPLC |
| 英文关键词: Yiqi Yangxue Oral Liquid Preservatives Content Determination HPLC |
| 基金项目:国家药品监督管理局中成药质量评价重点实验室开放课题(JXKL-2023-02)。 |
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| 中文摘要: |
| 目的：建立HPLC法同时测定益气养血口服液中苯甲酸、山梨酸钾、羟苯甲酯、羟苯乙酯、羟苯丙酯、羟苯丁酯6种防腐剂的含量。方法：采用Agilent5TC-C18(250mm×4.6mm,5μm)色谱柱：以甲醇-0.01mol/L乙酸铵溶液为流动相，梯度洗脱，流速为1.0mL/min;检测波长为230nm(0~11min,苯甲酸）；256nm(11~40min,山梨酸钾、羟苯酯类）；进样量为10μL,柱温为25℃。结果：6种防腐剂在各自线性范围内线性关系良好(r≥0.9998);平均加样回收率分别99.9%~104.3%,RSD分别为0.53%~1.40%(n=6)。结论：本法简便、灵敏，重现性好，可用于益气养血口服液的防腐剂的限量测定。 |
| 英文摘要: |
| Objective To establish an HPLC method for the simultaneous content determination of benzoic acid, potassium sor.bate, methyl p - hydroxybenzoate, ethyl p - hydroxybenzoate, propyl p - hydroxybenzoate, butyl p- hydroxybenzoate in Yigi Yangxue Oral Liquid. Methods "The chromatographic separation was performed on an Agjlent 5'Tc- Cys column (250 mm x 4.6 mm, 5um) column with Methanol -0. 0l mol/L ammonium acetate acid solution as the mobile phase ( gradient elution). "The flow rate wasI ml, " min~’ and the detection wavelengths were set at 230 nm for benzoic acid , 256 nm for potassium sorbate, methvl p - hydroxybenzoate, ethyl p - hydroxybenzoate, propyl p - hydroxybenzoate, butyl p -- hydroxybenzoate. the injection volume wad 110 uL, theColumn temperature was set at 25 9c. Results Six preservatives showed good linear relationship within their own rnges (r20. 9995 )whose average recoveries were 99.9% -104.3% with the RSDs of 0.53%-1.40% (n=6). Conclusion The method was stable.sensitive and reproducible, which can be used for the determination of preservatives of Yigi Yangxue Oral Liquid. |
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