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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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