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High performance liquid chromatographic detection method for formaldehyde content in ranitidine hydrochloride

A technology of ranitidine hydrochloride and high performance liquid chromatography, which is applied in the field of high performance liquid chromatography analysis and detection of formaldehyde content in ranitidine hydrochloride, can solve the problems such as the inability to detect the formaldehyde content of ranitidine hydrochloride, and achieve reliable Effective testing standards, simple configuration, and good test results

Active Publication Date: 2020-04-10
ZENJI RES LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Purpose of the invention: the purpose of this invention is to provide a high-performance liquid chromatography analysis and detection method of formaldehyde content in ranitidine hydrochloride, which solves the problem that the formaldehyde content of ranitidine hydrochloride cannot be detected in the prior art

Method used

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  • High performance liquid chromatographic detection method for formaldehyde content in ranitidine hydrochloride

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Experimental program
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Effect test

Embodiment 1

[0050] The establishment process of the inventive method:

[0051] 1. Instruments and reagents

[0052] Instrument: high performance liquid chromatography (Shimadzu 20A), DAD detector, water chromatography workstation

[0053] Reagent: Acetonitrile, Beijing Bailingwei Technology Co., Ltd., HPLC grade;

[0054] 2,4-Dinitrophenylhydrazine: Suzhou Crest;

[0055] Formaldehyde: Sinopharm Reagent Company, analytically pure;

[0056] 2. Establishment of a determination method for formaldehyde content in ranitidine hydrochloride

[0057] (1) Determination of the detection wavelength: according to the physicochemical properties and chemical structures of ranitidine hydrochloride and formaldehyde, adopt the DAD detector condition, and select 365nm as the absorption wavelength.

[0058] (2) Linearity and range

[0059]Formaldehyde derivative control solution: Accurately weigh 10mg of formaldehyde into a 10ml measuring bottle, add water to dilute to the 10ml mark, then accurately me...

Embodiment 2

[0069] High performance liquid chromatography: Diana U3000-DAD detector

[0070] Mobile Phase: Phase A: Water

[0071] Phase B: Acetonitrile

[0072] Mobile phase A: Mobile phase B is 40:60 isogradient for 30 minutes, and the isogradient is as follows:

[0073] Elution time (minutes) aqueous solution Acetonitrile 0 40 60 A 40 60

[0074] Chromatographic column: YMC-Pack ODS-A (4.6*250mm, 5um)

[0075] Detection wavelength: 365nm

[0076] Flow rate: 1.0ml / min

[0077] Column temperature: 25°C

[0078] Injection volume: 10ul

[0079] Solution preparation: Accurately weigh 100mg of 2,4-dinitrophenylhydrazine, put it into a 10ml measuring bottle, add acetonitrile to dilute to the 10ml mark, and use it as 2,4-dinitrophenylhydrazine mother solution; accurately weigh about 10mg of formaldehyde, to In a 10ml measuring bottle, add water to dilute to the 10ml mark, accurately measure 1ml, add water to the 10ml measuring bottle, add water to dilute to ...

Embodiment 3

[0082] High performance liquid chromatography: Diana U3000-DAD detector

[0083] Mobile Phase: Phase A: Water

[0084] Phase B: ethanol and isopropanol, wherein the volume ratio of ethanol and isopropanol is 1:1; the aqueous solution and organic solvent are gradient eluted for 60 minutes according to the following ratio:

[0085] Elution time (minutes) aqueous solution ethanol and isopropanol 0 50 50 60min 30 70

[0086] Chromatographic column: YMC-Pack ODS-A (2.0*150mm, 3um);

[0087] Detection wavelength: 365nm;

[0088] Flow rate: 1.0ml / min;

[0089] Column temperature: 25°C;

[0090] Injection volume: 10ul;

[0091] Solution preparation: Accurately weigh 100mg of 2,4-dinitrophenylhydrazine, put it into a 10ml measuring bottle, add acetonitrile to dilute to the 10ml mark, and use it as 2,4-dinitrophenylhydrazine mother solution; accurately weigh about 10mg of formaldehyde, to In a 10ml measuring bottle, add water to dilute to the 10ml mar...

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Abstract

The invention discloses a high performance liquid chromatographic detection method for formaldehyde content in ranitidine hydrochloride. The high performance liquid chromatographic detection method takes an organic solvent and water as mobile phases, and adopts gradient elution to determine the formaldehyde content. During determination, a derivatization reagent is adopted for derivatization treatment of formaldehyde, a test sample is prepared into a test sample derivative solution with a diluent, a formaldehyde solution is prepared into a formaldehyde derivative control solution with a diluent, the test sample derivative solution and the formaldehyde derivative control solution are taken respectively for direct sample introduction, and chromatograms are collected; and the content of formaldehyde in ranitidine hydrochloride is calculated according to an external standard method. The high performance liquid chromatographic detection method provided by the invention has the advantages ofsimple operation, high sensitivity, quantifiable determination, high precision and good reproducibility, and meets the process production requirements.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a high performance liquid chromatography analysis and detection method for formaldehyde content in ranitidine hydrochloride. Background technique [0002] Ranitidine hydrochloride N-[2-[[5-[(dimethylamino)methyl]furfuryl]thio]ethyl]-N'-methyl-2-nitrovinylidenediamine monohydrochloride; RanitidineHydr ochloride; Ranitidine hcl; (E)-N-{ 2-[({5-[(dimethylamino)methyl]furan-2-yl}methyl)sulfanyl]ethyl}-N'-methyl-2-nitroethene-1,1-diamine hydrochloride; (E)-N-[ 2-({[5-(dimethylamino)furan-2-yl]methyl}sulfanyl)et hyl]-N'-methyl-2-nitroethene-1,1-diamine hydrochloride(1:1) is a histamine H2 Receptor blocker, its CAS number is: 71130-06-8, its molecular formula is C13H22N4O3S·HCl, its molecular weight is 350.86, its chemical structure is: [0003] [0004] Ranitidine hydrochloride is used to treat gastric ulcer, reflux esophagitis, Zoller-Ellison syndrome, and it is included in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/067G01N2030/047
Inventor 赵文慧王晶晶马燕李乃文
Owner ZENJI RES LAB
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