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A kind of detection method of isomer in valsartan hydrocarbon compound

A valsartan hydrocarbon compound and detection method technology, applied to measuring devices, instruments, scientific instruments, etc., to achieve high separation, high system applicability, and simple operation

Active Publication Date: 2019-04-12
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no documented method for the detection of isomers in valsartan hydrocarbons

Method used

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  • A kind of detection method of isomer in valsartan hydrocarbon compound
  • A kind of detection method of isomer in valsartan hydrocarbon compound
  • A kind of detection method of isomer in valsartan hydrocarbon compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] 1) Experimental materials and instrument conditions

[0022] High performance liquid chromatography: Shimadzu LC-15C; Chromatographic column: 5μm, 4.6×250 mm, OD column; Chromatographic conditions: Flow rate: 0.6mL / min; Column temperature: 30℃; Injection volume: 10μl; Running time: 30min; detection wavelength: 222nm; mobile phase: n-hexane: isopropanol: trifluoroacetic acid: dimethylamine, the volume ratio is 70:30:0.1:0.1.

[0023] 2) Experimental steps

[0024] Prepare blank solution: mobile phase.

[0025] Preparation of enantiomer localization solution: Accurately weigh 5.29 mg of valsartan alkylate isomer reference substance, put it in a 10ml volumetric flask, add mobile phase to dissolve and dilute to the mark, and shake well.

[0026] Preparation of control solution: Accurately weigh 12.51mg of valsartan alkylate reference substance, put it in a 25ml volumetric flask, add mobile phase to dissolve and dilute to the mark, and shake well.

[0027] Preparation of ...

Embodiment 2

[0029] Embodiment 2 detection method system applicability test of the present invention

[0030] Prepare blank solution, enantiomer localization solution, contrast solution and need testing solution as described in Example 1, then dilute enantiomer localization solution 100 times, then accurately measure 2mL, dilute 10mL, as the system Suitability solution.

[0031] After the system is balanced, add the above-mentioned solutions respectively, record the chromatogram, and obtain the system suitability spectrum as follows: Figure 5 As shown, the obtained system adaptability results are shown in Table 1.

[0032] Table 1 - System Suitability Test Results

[0033]

Embodiment 3

[0034] Embodiment 3 detection method limit test of the present invention

[0035] Prepare quantitative limit solution: take 1 mL of the enantiomeric localization solution prepared in Example 1, dilute 100 times with mobile phase, then accurately measure 3 mL and add mobile phase to dilute to a 25 mL measuring bottle, then accurately measure 1 mL and add The mobile phase was diluted to 10mL and prepared.

[0036] Preparation of detection limit solution: Accurately measure 3mL of quantification limit solution, and then dilute to 10mL with mobile phase to prepare.

[0037] Assay method and result, as described in embodiment 1, chromatographic conditions are measured, and the result obtained is as shown in table 2.

[0038] Table 2 - Limit test results

[0039]

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Abstract

The invention provides a detection method for isomers in valsartan hydrocarbons. The detection method has high chromatographic peak resolution and high system applicability to the isomers in the valsartan hydrocarbons, and the precision, limit of quantitation, limit of detection, repeatability, linearity, range and stability are all in line with the standard. The detection method for the isomers in the valsartan hydrocarbons is proposed for the first time. The method has the advantages of good system applicability, high precision, good stability and the like. The detection method has simple operation, short used time, low cost and short time consuming.

Description

technical field [0001] The invention relates to an HPLC method for detecting isomers in valsartan hydrocarbons, belonging to the technical field of drug analysis. Background technique [0002] Valsartan (valsartan), chemical name: N-pentanoyl-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl ]-L-valine is an angiotensin II receptor antagonist antihypertensive drug, which acts to block the type I (AT1) receptor of angiotensin II, and angiotensin II plasma The level rises, stimulates the unblocked AT2 receptors, and at the same time counteracts the effect of AT1 receptors, thereby achieving the effect of dilating blood vessels and lowering blood pressure. The chemical name of valsartan alkylate is N-[(2'-cyano-1,1'-biphenyl-4-yl)methyl]-L-valine methyl ester hydrochloride, which is a synthetic valsartan The key intermediate of valsartan, the chemical name of valsartan is N-pentanoyl-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl] Methyl]-L-valine, valsartan is the configu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 姜春来唐志娟祁红林张志新谢斌陈新民
Owner 珠海润都制药股份有限公司
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