Impurity separation and detection method for telmisartan

A technology of telmisartan and detection method, which is applied in the field of telmisartan impurity separation and detection, can solve problems such as difficult separation and inability to achieve complete separation

Inactive Publication Date: 2018-05-29
南京迈迪信泽医药科技开发有限公司
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  • Claims
  • Application Information

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Problems solved by technology

[0010] Due to the similar structure, the separation of the two is difficult. In the related substance method of telmisartan recorded in the prior art, the degree of separation of impurities E and F is only 0.248, which cannot be completely separated (see figure 1 )

Method used

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  • Impurity separation and detection method for telmisartan
  • Impurity separation and detection method for telmisartan
  • Impurity separation and detection method for telmisartan

Examples

Experimental program
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Embodiment 1

[0128] Step 1, solution preparation:

[0129] Take an appropriate amount of telmisartan raw material or preparation powder, add 100 μl of 1mol / L sodium hydroxide to aid dissolution, dilute with methanol to 0.5mg / ml, and make the test solution;

[0130] Dilute it again as needed to make a 5 μg / ml solution as its own reference solution;

[0131] Step 2, system suitability solution preparation:

[0132] Take each appropriate amount of each impurity reference substance (A, B, C, E, F, G, H, I, intermediate ester), dissolve it with methanol and quantitatively dilute it to make a solution containing 1 mg per 1 ml, and store it as each impurity reference substance solution; measure each impurity reference substance (A, B, C, E, F, G, H, I, intermediate ester) stock solution 1ml and telmisartan raw material or preparation powder amount, add methanol quantitative dilution to make each 1ml of a mixed solution containing 2 μg of each impurity and 0.5 mg of telmisartan is used as a syst...

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Abstract

The invention relates to an impurity separation and detection method for telmisartan. The method comprises the following steps: 1, dissolving a raw medicament of the telmisartan or a preparation of the telmisartan into a methanol solution to obtain a test sample solution; 2, injecting the test sample solution into a high performance liquid chromatograph to obtain a chromatogram; 3, calculating thecontent of the telmisartan and impurities thereof according to a peak area of the chromatogram, wherein high performance liquid chromatographic conditions are as follows: a chromatographic column isODS-2C18, the flow velocity is 1.0ml / min, the column temperature is 40 DEG C, the wavelength is 230nm, and the sample size is 10 mu l. A gradient elution table is as follows (shown in the specification).

Description

technical field [0001] The invention relates to a method for detecting impurities in pharmaceutical compounds, in particular to a method for separating and detecting impurities in telmisartan Background technique [0002] Telmisartan is a non-peptide angiotensin II receptor antagonist, which can selectively and irreversibly block AT1 receptors without affecting other receptor systems, especially those involving the cardiovascular system. It is mainly used clinically for the treatment of essential hypertension. [0003] Telmisartan has a high bioavailability among similar drugs, especially the one with the longest half-life. It can be taken once a day, one capsule each time, and can stably lower blood pressure within 24 hours. obvious advantage. [0004] During the synthesis of telmisartan, some impurities will remain, such as impurity E and impurity F [0005] Their structure is as follows: [0006] Impurity E: [0007] Molecular weight: 428.17 [0008] Impurity F: ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 叶戎
Owner 南京迈迪信泽医药科技开发有限公司
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