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Method for analyzing related substances of terbutaline sulfate via high performance liquid chromatography

A technology of terbutaline sulfate and high performance liquid chromatography, which is applied in the field of analyzing terbutaline sulfate-related substances, can solve the problems of limited impurity detection ability, and achieve the goals of improving economic applicability, good sensitivity, and improving safety Effect

Active Publication Date: 2019-07-26
SHANGHAI XUDONG HAIPU PHARMA
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  • Abstract
  • Description
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Problems solved by technology

The above method has limited ability to detect impurities, and the quality control of the product needs to be further improved

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  • Method for analyzing related substances of terbutaline sulfate via high performance liquid chromatography
  • Method for analyzing related substances of terbutaline sulfate via high performance liquid chromatography
  • Method for analyzing related substances of terbutaline sulfate via high performance liquid chromatography

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Embodiment Construction

[0038] The technical solution of the present invention is described in detail below. The embodiments of the present invention are only used to illustrate the technical solutions of the present invention without limitation. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the invention can be modified or equivalently replaced , without departing from the spirit and scope of the technical solution of the present invention, all of which shall be covered by the claims of the present invention.

[0039] In this embodiment, the impurities that may exist in the synthetic process of terbutaline sulfate were deeply analyzed, and 10 impurities were identified, see Table 2 for details.

[0040] Table 2 Terbutaline Sulfate Impurity Spectrum Analysis Summary Table

[0041]

[0042]

[0043]

[0044] During the development process, the Pharmacopoeia me...

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Abstract

The invention provides a method for analyzing related substances of terbutaline sulfate via high performance liquid chromatography. A C18 reversed chromatographic column is used, a mobile phase is a mixture of a 0.05 M ammonium acetate buffer solution with pH 4.0 and methanol, gradient elution is carried out, and qualitative and quantitative detection of terbutaline and 9 impurities is achieved byonce sample injection. Compared with the prior art, the method provided by the invention has the advantages of being able to not only detect more impurities, but also having good sensitivity to various impurities. In the specific application, according to the detection result of each batch of samples, the limit of the key impurity formulated, and the economic applicability in the actual production process is greatly improved.

Description

technical field [0001] The invention relates to a method for analyzing impurities involved in compound synthesis, in particular to a method for analyzing terbutaline sulfate related substances. Background technique [0002] Terbutaline sulfate, the English name is Terbutaline Sulfate, the chemical name is (±)α-[(tert-butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1), and the molecular formula is C 12 h 19 NO 3 ) 2 ·H 2 SO 4 , the molecular weight is 548.66, the CAS number is 23031-32-5, and the structural formula is as follows: [0003] [0004] In the manufacture of potent active molecules for pharmaceutical products, impurities are critical quality attributes that affect the product. The structure, physical and chemical properties and toxicity of impurities are complex, so the inspection and research of related substances is often one of the difficulties in drug development. In addition to the pharmacological activity of the main component, the adverse...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/065
Inventor 郭华龙杨易可梁屹张帆陈小林
Owner SHANGHAI XUDONG HAIPU PHARMA
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