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A method for detecting impurity cis-perhydroisoindole in mitiglinide calcium

A technology of mitiglinide calcium and perhydroisoindole, which is applied in the field of medicine to achieve the effects of strong specificity and improved drug safety

Active Publication Date: 2021-03-02
SHANDONG BOYUAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after retrieval, there is no report on the content detection method of cis-perhydroisoindole in mitiglinide calcium

Method used

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  • A method for detecting impurity cis-perhydroisoindole in mitiglinide calcium
  • A method for detecting impurity cis-perhydroisoindole in mitiglinide calcium
  • A method for detecting impurity cis-perhydroisoindole in mitiglinide calcium

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] 1 Instruments and materials

[0031] 1.1 Instruments: Triple Quad4500 mass spectrometer (AB, USA), LC20A high performance liquid chromatograph (Shimadzu, Japan);

[0032] 1.2 Reagents: Methanol and acetonitrile are of mass spectrometry grade, acetic acid (chromatographic grade), and water is ultrapure water.

[0033] 2 Methods and results

[0034] 2.1 Chromatography and mass spectrometry conditions

[0035] Chromatographic column: MGⅢC 18 (2.0×100mm, 3μm, Shiseido), flow rate: 0.1ml / min, column temperature: 40°C, injection volume: 1μl, mobile phase: acetonitrile (containing 0.1% acetic acid)-water (containing 0.1% acetic acid). The gradient elution table is shown in Table 3.

[0036] Table 3 Gradient elution table

[0037]

[0038] Ion source: electrospray ionization source (ESI), positive ion mode: select multiple reaction detection scanning (MRM) mode, spray voltage (IS) 5500V; drying gas temperature 550 ° C; atomization gas (Gas1) 50psi; auxiliary gas (Gas2 ...

Embodiment 2

[0066] Embodiment 2: the detection of actual sample

[0067] 1) Get the former medicine of mitiglinide calcium, dissolve or constant volume with methanol, be mixed with the solution that contains 0.5mg mitiglinide calcium in 1ml, as need testing solution;

[0068] 2) Take the test solution prepared in step 1), adopt the same instruments and reagents as in Example 1, and carry out LC-MS / MS detection according to the chromatographic and mass spectrometry conditions shown in step 1) 2.1.

[0069] 3) According to the standard curve obtained in Example 1, find out the impurity cis-perhydroisoindole content in mitiglinide calcium.

[0070] Adopt above-mentioned method to detect three batches of samples, the result is as follows:

[0071] Table 8 Test results

[0072] Sample lot number 1 2 3 cis perhydroisoindole content% 0.016 0.015 0.013

[0073] .

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Abstract

The invention discloses a method for detecting impurity cis-perhydroisoindole in mitiglinide calcium. The method uses MGⅢC18 as a chromatographic column, uses LC-MS / MS detection method to carry out qualitative and quantitative analysis of cis-perhydroisoindole in mitiglinide calcium, and has carried out methodological verification. It is proved by experiments that this method has specificity. Strong, fast, sensitive, accurate and so on. The present invention establishes the qualitative and quantitative method for the impurity cis-perhydroisoindole in the mitiglinide calcium for the first time, which facilitates the quality control of the mitiglinide calcium, thereby improving the drug safety of the mitiglinide calcium.

Description

technical field [0001] The invention relates to a detection method of cis-perhydroisoindole, an impurity in mitiglinide calcium, and belongs to the technical field of medicine. Background technique [0002] Miglinide Calcium (mitiglinide Calcium) is an ATP-dependent potassium ion channel blocker developed by KISSEIPHARMACEUTICAL. It was first launched in Japan in April 2004, and launched in South Korea in 2006. The original research product has been approved for marketing in China, 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. Hypoglycemia, which has obvious advantages over other traditional hypoglycemic drugs, can be used as a first-line diabetes treatment drug and has a broad market prospect. [0003] Cis-perhydroisoindole is not only the reaction material of mitigli...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 王晓丹袁恺孙庆伟杨上任苏曼
Owner SHANDONG BOYUAN PHARM CO LTD
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