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| Determination of Thioctic Acid Tablets and Their Degradation Products by HPLC |
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| DOI：10.3969/j.issn.1004-4957.年份.月份 |
| KeyWord:thioctic acid tablet thioctic acid degradation products HPLC |
| Author | Institution |
| 叶汝汉，张怡，彭蕾，孙晋红，张嘉颖，张慧影，伍迪科，张萍 |
1.广州法尔麦兰药物技术有限公司;2.中国广州分析测试中心 |
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| Abstract: |
| A high-performance liquid chromatographic（HPLC） method for the determination of relative substances in thioctic acid tablets was developed.The separation of analyte was performed on a Waters XBridge column（5 μm，150 mm×4.6 mm） with phosphate buffer（pH value was adjusted to 2.5 with phosphoric acid）-acetonitrile-methanol（50∶45∶5） as mobile phase，at a flow rate of 1.0 mL/min and an injection volume of 20 μL.The photo-diode array detector（PDA） was set at 220 nm，with full scan range of 200-400 nm.The column temperature was ambient.Under the above chromatographic conditions，the calibration curve was linear（r=0.999 9） in thioctic acid concentration range of 0.4-20.0 mg/L.The limit of detection（LOD） for thioctic acid was 0.2 mg/L and the limit of quantitation（LOQ） was 0.6 mg/L.The relative standard deviation（RSD，n=12） was 3.4%,and the average spiked recovery was 100.9% with RSD of 2.0%.The proposed method could be applied in the determination of relative substances in thioctic acid tablets with the advantages of simplicity，rapidity，accuracy，good selectivity and high sensitivity. |
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