高效液相色谱法测定利伐沙班中的有关物质

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Abstract Objective To establish a method to determine the related substance in Rivaroxaban.Methods HPLC method was used,column was Diamonsil C₈ (250 mm×4.6 mm,5 μm),the mobile phase A was treated with 5 mmol/L ammonium acetate solution (containing 0.3% 25% tetramethyl ammonium hydroxide solution,adjusted to pH 4.8 with glacial acetic acid)-acetonitrile (80∶20),the mobile phase B was treated with 5 mmol/L ammonium acetate solution (containing 0.3% 25% tetramethyl ammonium hydroxide solution,pH was adjusted to 4.8 with glacial acetic acid)-acetonitrile (10:90),which was used as gradient elution The detection wavelength was 250 nm.Results The resolution of rivaroxaban and its related substance was above 2.0,detection limit was 0.2-0.5 ng,quantification limit was 1.0-2.0 ng.Conclusion The method is suitable for the determination of related substance in Rivaroxaban.

Key words： HPLC Rivaroxaban Related substance Determination

Received: 14 April 2017

PACS:

R927

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	Articles by authors
	HUANG Yan
	CHEN Xue-yun
	YANG Xue-feng
	LIU Xia

Cite this article:

HUANG Yan,CHEN Xue-yun,YANG Xue-feng, et al. Determination of related substances in Rivaroxaban by HPLC[J]. 中国当代医药, 2017, 24(24): 78-81.

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http://dangdaiyiyao.com/EN/ OR http://dangdaiyiyao.com/EN/Y2017/V24/I24/78

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