High performance liquid chromatography analysis method and detection method for impurities in Telmisartan medicine

A technology of high performance liquid chromatography and analysis method, which is applied in the field of high performance liquid chromatography analysis method and the detection of impurities in telmisartan medicine, can solve the problems of difficult detection process, time-consuming reagent dosage, and high detection cost, and achieves shortened time. Analysis time, simple operation, and the effect of changing many operation steps

Active Publication Date: 2018-04-27
湖南威特制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Due to the similarity of the above impurity structures, it brings difficulties to the follow-up detection process. For the detection of the ingredients in the telmisartan tablet, high performance liquid chromatography is used in the prior art, and gradient elution is used in the European Pharmacopoeia, but it cannot Telmisartan and the above 8 impurities were all detected, and the baseline was poor and there was a lot of interference
The method in the Chinese Pharmacopoeia adopts isocratic elution, and it is impossible to collect all the above 8 impurities, and the impurities behind the main component need to be measured after prolonging the collection time. This determination method is not only time-consuming but also requires a large amount of reagents. The detection cost is higher

Method used

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  • High performance liquid chromatography analysis method and detection method for impurities in Telmisartan medicine
  • High performance liquid chromatography analysis method and detection method for impurities in Telmisartan medicine
  • High performance liquid chromatography analysis method and detection method for impurities in Telmisartan medicine

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Experimental program
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Effect test

preparation example 1

[0047] Accurately weigh telmisartan and impurity A, impurity B, impurity C, impurity E, impurity F, impurity G, impurity H, impurity I, add 0.005mol / L sodium hydroxide methanol solution to prepare a solution, wherein , the mass concentration of telmisartan is 0.5 mg / mL; the respective mass concentrations of impurity A, impurity B, impurity C, impurity E, impurity F, impurity G, impurity H and impurity I in the solution are 5 μg / mL respectively.

Embodiment 1

[0049] The solution in the preparation example 1 is analyzed with high performance liquid chromatography, and the record chromatogram, the chromatographic condition of described high performance liquid chromatography is as follows:

[0050] Chromatographic column: 150mm×4.6μm 5μm C18, column temperature 35℃

[0051] Wavelength: 230nm

[0052] Injection volume: 10μL

[0053] Flow rate: 1.0mL / min

[0054] The first mobile phase: add 2.0g potassium dihydrogen phosphate and 3.8g sodium n-pentanesulfonate monohydrate to 1L water, adjust the pH value to 3.5 with phosphoric acid;

[0055] The second mobile phase: the volume ratio of methanol and acetonitrile is 50:50;

[0056] In the gradient elution, the total volume of the mobile phase is 100%, and the conditions of the gradient elution are set according to time as shown in Table 1:

[0057] Table 1

[0058] time (min)

The first mobile phase (%)

Second mobile phase (%)

0-10

50

50

10-30

50...

Embodiment 2

[0065] The solution in the preparation example 1 is analyzed with high performance liquid chromatography, and the record chromatogram, the chromatographic condition of described high performance liquid chromatography is as follows:

[0066] Chromatographic column: 150mm×4.6μm 5μm C18, column temperature 35℃

[0067] Wavelength: 230nm

[0068] Injection volume: 10μL

[0069] Flow rate: 1.0mL / min

[0070] The first mobile phase: add 2.0g potassium dihydrogen phosphate and 3.8g sodium n-pentanesulfonate monohydrate to 1L water, adjust the pH value to 3.0 with phosphoric acid;

[0071] The second mobile phase: the volume ratio of methanol and acetonitrile is 50:50;

[0072] In the gradient elution, the total volume of the mobile phase is taken as 100%, and the conditions of the gradient elution are set as shown in Table 3 by time.

[0073] table 3

[0074]

[0075] The obtained chromatogram is as figure 2 shown, seen, figure 2 9 absorption peaks were obtained in the so...

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Abstract

The invention relates to the detection of Telmisartan, and particularly discloses a high performance liquid chromatography analysis method and a detection method for impurities in a Telmisartan medicine. The analysis method is capable of completely and separately detecting eight impurities of A, B, C, E, F, G, H, and I in the Telmisartan and the Telmisartan medicine. A Telmisartan sample is detected by using the high performance liquid chromatography analysis method, the medicine can be rapidly detected whether to contain one or more of the above eight impurities through one time of the chromatographic analysis, and the impurity content can be detected through the high performance liquid chromatography analysis, so the purpose of controlling the pharmaceutical quality is achieved. The detection method is capable of greatly shortening the analysis time, simple in operation, reliable and accurate. The previous factors, such as multiple operating steps, long analysis time, and more interference factors, are changed. The detection method is an effective method for the Telmisartan pharmaceutical research and the production process quality control.

Description

technical field [0001] The invention relates to the detection of telmisartan, in particular to a high-performance liquid chromatography analysis method and a detection method for impurities in telmisartan medicine. Background technique [0002] Telmisartan (Telmisartan) is 4'-[(1,4'-dimethyl-2'-propyl[2,6'-di-1H-benzimidazole]-1'-yl)methyl] -[1,1'-Diphenyl]-2-carboxylic acid, the molecular formula is C 33 h 30 N 4 o 2 , Telmisartan Tablets, used for the treatment of adults with essential hypertension to reduce cardiovascular risk, this product is suitable for those aged 55 and above who are at high risk of severe cardiovascular events and cannot accept angiotensin conversion Enzyme (ACE) inhibitor therapy to reduce the risk of myocardial infarction, stroke or death from cardiovascular disease in patients. [0003] Telmisartan tablets, dispersible tablets, capsules and other dosage forms are currently on the market. Telmisartan has a variety of impurities, including the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/86
CPCG01N30/86
Inventor 何亮
Owner 湖南威特制药股份有限公司
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