Determination of Related Substances in Ezetimibe by RP-HPLC

ZHOU Zeng-hui; ZHUANG He-fei; YU Xin; ZENG Yan; BI Kai-shun; CHEN Xiao-hui

doi:10.11653/syfj2013190159

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Determination of Related Substances in Ezetimibe by RP-HPLC

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- Determination of Related Substances in Ezetimibe by RP-HPLC
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 19, Issue 19, Pages: 159-163(2013)
- 作者机构：
- 作者简介：
- 基金信息：
- DOI：10.11653/syfj2013190159
  CLC：
- Published：2013
- 稿件说明：
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ZHOU Zeng-hui, ZHUANG He-fei, YU Xin, et al. Determination of Related Substances in Ezetimibe by RP-HPLC[J]. Chinese journal of experimental traditional medical formulae, 2013, 19(19): 159-163.
DOI：

ZHOU Zeng-hui, ZHUANG He-fei, YU Xin, et al. Determination of Related Substances in Ezetimibe by RP-HPLC[J]. Chinese journal of experimental traditional medical formulae, 2013, 19(19): 159-163. DOI： 10.11653/syfj2013190159.

摘要

目的: 建立测定依折麦布原料药中有关物质的RP-HPLC测定法。方法: Phenomenex Luna C18色谱柱(4.6 mm ×150 mm

5 μm)

流动相0.01%磷酸(A)

乙腈(B)

梯度洗脱

流速1.0 mL·min-1

检测波长231 nm

柱温35℃。结果: 依折麦布与有关物质分离良好;有关物质A

C在0.035~0.8 mg·L-1峰面积与浓度呈良好的线性关系

r分别为0.999 7

0.999 4

0.999 9(n=6)。结论: 方法操作简便

灵敏度高

专属性强

重复性好

可用于依折麦布原料药中有关物质的检查。

Abstract

Objective: To establish a RP-HPLC method for the determination of related substances in ezetimibe. Method: The method was performed on a Phenomenex Luna C18 column (4.6 mm×150 mm

5 μm) using a mobile phase consisting of 0.01% phosphoric acid as the mobile phase A

acetonitrile as the mobile phase B with gradient elution. The flow rate was 1.0 mL·min-1 and the detection wavelength was set at 231 nm. The column temperature was set at 35℃. Result: Related substances were completely separated from ezetimibe. The standard curves of substances A

B and C were linear in the range of 0.035-0.8 mg·L-1(r=0.999 7

0.999 4

0.999 9) (n=6)

respectively. Conclusion: The method is simple

sensitive with high specificity and repeatability. It is suitable for the determination of related substances in ezetimibe.

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Related Author

ZHANG Yun1

SONG Xu-feng2

CHEN Yong

ZENG Ping

WEN Qing-wei

HU Feng

YANG Chen

LIU Ying-li

Related Institution

Pharmacy College of Liaoning University of Traditional Chinese Medicine

Ethnic Pharmaceutical Institute of Southwest University for Nationalities

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Henan Collenge of Traditional Chinese Medicine

Nanjing University of Chinese Medicine

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