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Method for separating and detecting related substances of Riociguat medicinal raw material by using HPLC (high performance liquid chromatography)

A technology related to substances and raw materials, applied in the field of pharmaceutical and chemical industries, can solve problems such as poor precision and accuracy, poor peak shape symmetry, poor column efficiency, etc., and achieve good accuracy, good stability indicating ability, exclusive good sex effect

Active Publication Date: 2015-02-25
SUNSHINE LAKE PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

And because of the polyamino characteristics of riociguat and its related substances, it is easy to interact with the silanol on the chromatographic column, resulting in problems such as tailing, poor peak symmetry, and poor column efficiency. Medium precision and accuracy will be relatively poor

Method used

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  • Method for separating and detecting related substances of Riociguat medicinal raw material by using HPLC (high performance liquid chromatography)
  • Method for separating and detecting related substances of Riociguat medicinal raw material by using HPLC (high performance liquid chromatography)
  • Method for separating and detecting related substances of Riociguat medicinal raw material by using HPLC (high performance liquid chromatography)

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Embodiment Construction

[0020] A kind of method that adopts HPLC to separate and detect the related substance of riociguat crude drug provided by the invention is characterized in that in the high performance liquid chromatography system, adopts reversed-phase chromatographic column (such as with octadecylsilane bonded phase or octadecylsilane Alkylsilane bonded phase as the chromatographic column of the packing); the mobile phase is composed of the anion reagent aqueous solution or its mixed solution with the organic solution as the A phase and the organic solution as the B phase, and elutes; The related substances of Ociguat API were tested.

[0021] Wherein, the method of the present invention is carried out by adopting a gradient elution method. Gradient elution includes at least two stages of gradient changes, wherein the first stage of gradient changes is within 0 to 60 minutes, and the content of phase A in the mobile phase is 66% to 80%, volume ratio; the second stage of gradient changes is ...

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Abstract

The invention provides a method for separating and detecting related substances of a Riociguat medicinal raw material by using HPLC (high performance liquid chromatography). According to the method, an octadecylsilan bonded phase or octyl-silane bonded phase is used as a chromatographic column of filler, and an anion pair reagent solution is used as a buffer solution for eluting, and related substances in the Riociquat medicinal raw material are detected by an ultraviolet detector. The analyzing method has the advantages of good specificity, high sensitivity and good accuracy, and has relatively good stability indicating capability.

Description

technical field [0001] The invention relates to the field of medicine and chemical industry, more specifically, relates to a method for separating and measuring related substances of riociguat raw material medicine by using high performance liquid chromatography. Background technique [0002] Riociguat, chemical name N-[4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridine-3- Base]-5-pyrimidinyl]-N-methylcarbamate methyl ester (abbreviated as RCGT), its structural formula is as follows: [0003] [0004] CAS: 625115-55-1 Molecular weight: 422.42 [0005] It is a compound that can stimulate soluble guanylate cyclase (sGC) developed by Bayer Pharmaceutical Company of Germany. sGC regulates the vasodilation of multiple vascular beds by acting on cGMP, and can be used for the treatment of cardiovascular diseases or / and sexual function obstacle. At present, the oral tablet developed by Bayer Pharmaceuticals for the treatment of pulmonary arterial hypertension...

Claims

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Application Information

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IPC IPC(8): G01N30/89
Inventor 文景兵饶万兵刘国柱
Owner SUNSHINE LAKE PHARM CO LTD
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