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Detecting method of impurity succinic acid in S-benzylsuccinic acid

A benzyl succinic acid and detection method technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., to achieve strong specificity, good separation effect, and improve the effect of drug safety

Active Publication Date: 2019-04-05
SHANDONG BOYUAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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But after retrieval, there is no report about the content detection method of succinic acid in S-benzylsuccinic acid

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  • Detecting method of impurity succinic acid in S-benzylsuccinic acid
  • Detecting method of impurity succinic acid in S-benzylsuccinic acid
  • Detecting method of impurity succinic acid in S-benzylsuccinic acid

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Experimental program
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Effect test

Embodiment 1

[0032] 1 Instruments and materials

[0033] 1.1 Instrument: Waters Arc 2489 high performance liquid chromatography (Waters, USA);

[0034] 1.2 Reagents: methanol (chromatographic grade), phosphoric acid (chromatographic grade), water is ultrapure water.

[0035] 2 Methods and results

[0036] 2.1 Chromatographic conditions

[0037] Chromatographic column: Agilent ZORBAX SB-CN chromatographic column (4.6×250mm, 5μm), column temperature: 35℃, injection volume: 40μl;

[0038] Mobile phase A: methanol-water (containing 0.1% phosphoric acid) = 5:95, mobile phase B: methanol-water (containing 0.1% phosphoric acid) = 45:55, solvent: methanol-water = 5:95; flow rate: 1.0ml / min, see Table 1 for gradient elution conditions.

[0039] Detector: Waters 2489 ultraviolet detector, detection wavelength: 212nm.

[0040] 2.2 Preparation of solution

[0041] 2.21 Preparation of specific solution

[0042] Accurately weigh 31.15mg of succinic acid reference substance, put it in a 100ml mea...

Embodiment 2

[0082] Embodiment 2: the detection of actual sample

[0083] 1) Get S-benzylsuccinic acid, dissolve and constant volume with solvent, be mixed with the solution that contains 3mg S-benzylsuccinic acid in 1ml, as need testing solution;

[0084] 2) get succinic acid, dissolve and constant volume with solvent, be mixed with the solution that 1ml contains 0.003mg succinic acid, as reference substance solution;

[0085] 3) get the need testing solution prepared by step 1) and each 40 μ l of the reference solution prepared by step 2) directly (respectively) sample injection, adopt the exact same instruments and reagents as in Example 1, carry out according to the chromatographic conditions shown in 2.1 HPLC detection, record chromatogram;

[0086] 3) According to the external standard method, the content of impurity succinic acid in S-benzylsuccinic acid was calculated by peak area.

[0087] Adopt above-mentioned method to detect three batches of samples, the result is as shown in...

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Abstract

The invention discloses a detecting method of impurity succinic acid in S-benzylsuccinic acid. Agilent SB-CN is adopted as a chromatographic column, the HPLC detecting method is adopted to qualitatively and quantitatively detect the succinic acid in the S-benzylsuccinic acid, and methodology validation is conducted. The experimental results show that the method has the advantages of being high inspecificity, fast, sensitive and accurate. The qualitative and quantitative method of the impurity succinic acid in the S-benzylsuccinic acid is established for the first time, the mass of the S-benzylsuccinic acid can be conveniently controlled, and therefore drug safety of using the S-benzylsuccinic acid as an intermediate active component is improved.

Description

technical field [0001] The invention relates to a detection method of succinic acid, an impurity in S-benzylsuccinic acid, and belongs to the technical field of medicine. Background technique [0002] S-benzylsuccinic acid ((S)-2-Benzylsuccinic acid) is an important pharmaceutical intermediate, mainly used in the production of mitiglinide calcium. Miglinide Calcium is an ATP-dependent potassium ion channel blocker developed by KISSEIPHARMACEUTICAL. It was first launched in Japan in April 2004. It was launched in South Korea in 2006. In 2010, the original product was launched in China. It has been approved for marketing, and many pharmaceutical manufacturers in China have been approved for production. Miglinide calcium is clinically used to treat type 2 diabetes. Its mechanism of action is similar to that of sulfonylurea, but it works faster and has a shorter half-life. The hypoglycemia of hypoglycemia has obvious advantages over other traditional hypoglycemic drugs, and ca...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/047
Inventor 钱振英孙庆伟闫玲玲张秀云王娜
Owner SHANDONG BOYUAN PHARM CO LTD
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