| 引用本文: | 房冉,王晗,陈玉双,张佳茹,郑玉林.HPLC检测维生素B2片中有关物质的方法优化[J].中国现代应用药学,2020,37(22):2764-2769. |
| FANG Ran,WANG Han,CHEN Yushuang,ZHANG Jiaru,ZHANG Yulin.Improvement of Content Determination for Related Substances in Vitamin B2 Tablets by HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(22):2764-2769. |
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| 摘要: |
| 目的 优化维生素B2片中有关物质的检测方法。方法 采用Welch Ultimate AQ-C18柱（4.6 mm×250 mm，5 μm），流动相为0.1%磷酸水溶液（A）-乙腈（B），进行梯度洗脱；流速为1.0 mL·min-1；检测波长267 nm；柱温30℃。结果 各杂质与主成分峰分离度良好；杂质A在0.008 7~0.053 5 μg·mL-1（r2=0.998 1）、杂质B在0.019 8~0.812 3 μg·mL-1（r2=0.999 8）、杂质D在0.007 3~0.838 7 μg·mL-1（r2=1.000 0）、维生素B2在0.011 3~0.427 6 μg·mL-1（r2=0.999 4）内呈现良好的线性关系；杂质A、杂质B、杂质D平均回收率（n=9）分别为100.1%（RSD=1.6%）、100.6%（RSD=2.0%）和101.1%（RSD=1.1%）。结论 本检测方法专属性强、准确度高，可用于控制维生素B2片中的有关物质。 |
| 关键词: 维生素B2片 高效液相色谱法 有关物质 优化参数 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.22.013 |
| 分类号:R917.101 |
| 基金项目: |
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| Improvement of Content Determination for Related Substances in Vitamin B2 Tablets by HPLC |
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FANG Ran1, WANG Han1, CHEN Yushuang2, ZHANG Jiaru1, ZHANG Yulin2
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1.Shanghai University of Engineering Science, Shanghai 201620, China;2.Shanghai Maple Biological Technology Co., Ltd., Shanghai 201203, China
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| Abstract: |
| OBJECTIVE To optimize a method for related substances determination of vitamin B2 tablets. METHODS The Welch Ultimate AQ-C18 column(4.6 mm×250 mm, 5 μm) was used. The mobile phase A was 0.1% phosphoric acid solution and the mobile phase B was acetonitrile for gradient elution. The flow rate was 1.0 mL·min-1. The detection wavelength was 267 nm. The column temperature was 30 ℃. RESULTS The separation of impurity and principal component peak was good. The calibration curves were linear, the impurity A in range 0.008 7-0.053 5 μg·mL-1(r2=0.998 1), the impurity B in range 0.019 8-0.812 3 μg·mL-1(r2=0.999 8), the purity D in range 0.007 3-0.838 7 μg·mL-1 (r2=1.000 0) and vitamin B2 0.011 3- 0.427 6 μg·mL-1(r2=0.999 4). The average recoveries of impurity A, impurity B and impurity D were 100.1%(RSD=1.6%), 100.6%(RSD=2.0%) and 101.1%(RSD=1.1%). CONCLUSION This detection method has strong specificity and high accuracy, and can be used to control related substances in vitamin B2 tablets. |
| Key words: vitamin B2 tablets HPLC related substances optimize parameters |
