Detection method for related substances of telmisartan and telmisartan tablets

A technology for telmisartan and a detection method, applied in the field of pharmacy, can solve problems such as inability to separate, and achieve the effects of high accuracy, improved quality and safety, and good stability

Pending Publication Date: 2021-10-19
南京双科医药开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0016] This method is recorded in the "Chinese Pharmacopoeia" and is widely used in the detection of related substances in telmisartan and telmisartan tablets. However, only one known impurity is added to the system applicability test of this method. According to the "European Pharmacopoeia" ( Impurity D has an unknown structure, so it was not included in the study) and the commonly used telmisartan preparation process in my country (intermediate impurity: telmisartan methyl ester), there are 9 common known impurities in telmisartan-related research (see The following table), the inventors have found through experiments that the prior art cannot completely separate these 9 impurities

Method used

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  • Detection method for related substances of telmisartan and telmisartan tablets
  • Detection method for related substances of telmisartan and telmisartan tablets
  • Detection method for related substances of telmisartan and telmisartan tablets

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Effect test

Embodiment 1

[0104] Embodiment 1, detection method of the present invention, comprises the following steps:

[0105] (1) Chromatographic conditions:

[0106] Chromatographic column: Octadecylsilane bonded silica gel column 250×4.6mm, 5μm,

[0107] Detector: UV detector (detection wavelength 230nm),

[0108] Column temperature: 40°C,

[0109] Mobile phase A: 0.2% potassium dihydrogen phosphate solution (containing 0.34% sodium pentanesulfonate, adjusted to pH 3.0 with phosphoric acid),

[0110] Mobile phase B: methanol-acetonitrile (1:4),

[0111] Injection volume: 10μl,

[0112] Flow rate: 1.0ml / min,

[0113] Diluent: 0.005mol / L sodium hydroxide methanol solution,

[0114] Elution method:

[0115] Carry out gradient elution according to the following table:

[0116]

[0117] (2) Solution preparation

[0118] Blank solution: 0.005mol / L sodium hydroxide methanol solution

[0119] System Suitability Solution:

[0120] Weigh the appropriate amount of telmisartan reference substan...

Embodiment 2

[0136] Embodiment 2, the screening and optimization process of detection method of the present invention:

[0137] (1) Exploration of chromatographic conditions for related substances 1: (refer to the inspection method for related substances of telmisartan raw materials in the second part of the "Chinese Pharmacopoeia" 2015 edition) see the attached chromatogram figure 1 .

[0138] Chromatographic column: Octadecylsilane bonded silica gel column 150×4.6mm, 5μm

[0139] Detector: UV detector (detection wavelength 230nm)

[0140] Column temperature: 40°C

[0141] Mobile Phase A: Methanol

[0142] Mobile phase B: 0.1% potassium dihydrogen phosphate-methanol (35:65, containing 0.2% triethylamine, adjust the pH value to 5.0 with phosphoric acid)

[0143] Injection volume: 20μl

[0144] Flow rate: 1.0ml / min

[0145] The gradient conditions are shown in the table below:

[0146]

[0147] System Suitability Solution:

[0148] Weigh the appropriate amount of impurity A, imp...

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Abstract

The invention belongs to the field of pharmacy, and relates to a method for detecting related substances of telmisartan and telmisartan tablets. The detection method has the characteristics of high accuracy, good sensitivity, good stability and the like. The detection method comprises the following steps: (1) setting chromatographic conditions: a chromatographic column is an octadecyl silane bonded silica gel column, a mobile phase A is a 0.2% monopotassium phosphate solution, a mobile phase B is a mixed solution of methanol and acetonitrile in a volume ratio of 1: 4, and gradient elution is carried out; (2) preparing solutions including a blank solution, a system applicability solution, a test solution and a contrast solution, (3) testing the system applicability, and (4) respectively taking the blank solution, the system applicability solution, the test solution and the contrast solution in the testing process, injecting the solutions into a liquid chromatograph, recording a chromatogram, and measuring.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a method for detecting related substances of telmisartan and tablets thereof. Background technique [0002] Telmisartan (telmisartan), the chemical name is 4'-[(1,4'-dimethyl-2'-propyl[2,6'-di-1H-benzimidazole]-1'-yl) Methyl]-[1,1'-biphenyl]-2-carboxylic acid, the molecular formula is C 33 h 30 N 4 o 2 , is white or off-white crystalline powder, odorless and tasteless. Soluble in chloroform, slightly soluble in dichloromethane or dimethylformamide, slightly soluble in methanol, very slightly soluble in ethanol, almost insoluble in water, easily soluble in 1mol / L sodium hydroxide solution, It is very slightly soluble in 0.1mol / L hydrochloric acid solution. [0003] Telmisartan is a new type of antihypertensive drug, which is a specific angiotensin Ⅱ receptor (AT1 type) antagonist. Telmisartan substitutes for the angiotensin II receptor and binds with high affinity to the AT1 receptor ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N30/86G01N30/88
CPCG01N30/482G01N2030/484G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N30/86G01N30/88G01N2030/3007G01N2030/324G01N2030/8872
Inventor杨徐
Owner南京双科医药开发有限公司