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HPLC detection method for degradation impurities in lidocaine hydrochloride and preparation thereof

A technology of lidocaine hydrochloride and a detection method, which is applied in the field of pharmaceutical preparation and detection, can solve problems such as uncontrolled degradation of impurities, and achieve the effects of high sensitivity, strong specificity and good separation degree.

Pending Publication Date: 2021-08-06
TIANSHENG PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The current Chinese Pharmacopoeia Quality Standards for Lidocaine Hydrochloride and Lidocaine Hydrochloride Injection specified the specific impurity 2,6-dimethylaniline, but 2-(diethylbenzyl)-N-(2,6-di Methylphenyl)acetamide and N-(2,6-dimethylphenyl)-2-(ethylamino)acetamide were not controlled as degradation impurities

Method used

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  • HPLC detection method for degradation impurities in lidocaine hydrochloride and preparation thereof
  • HPLC detection method for degradation impurities in lidocaine hydrochloride and preparation thereof
  • HPLC detection method for degradation impurities in lidocaine hydrochloride and preparation thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0030] The instruments and setting conditions adopted in this embodiment are as follows:

[0031] High performance liquid chromatography: Shimadzu LC-20AT;

[0032] Chromatographic column: Thermo Hypersil GOLD Dim.(mm) C18, 250mm×4.6mm, 5μm;

[0033] Flow rate of mobile phase: 1mL / min;

[0034] Detection wavelength: 230nm;

[0035] Column temperature: 30°C;

[0036] Injection volume: 20uL;

[0037] Wherein the mobile phase: Phosphate buffer and acetonitrile (adjust the pH value to 8.0 with phosphoric acid) is configured as the mobile phase according to the mass and number ratio of 55:45, wherein the concentration of 0.01mol / L phosphate buffer is prepared in the following way: Take Dilute 1.3ml of lmol / L sodium dihydrogen phosphate solution and 32.5ml of 0.5mol / L disodium hydrogen phosphate solution to 1000ml with water and shake well.

[0038] Experimental steps:

[0039] Step 1: Solution preparation

[0040] System suitability solution: Take this product and impurities...

Embodiment 2

[0046] The instruments and setting conditions adopted in this embodiment are as follows

[0047] High performance liquid chromatography: Shimadzu LC-20AT;

[0048] Chromatographic column: Thermo Hypersil GOLD Dim.(mm) C18, 250mm×4.6mm, 5μm;

[0049] Flow rate of mobile phase: 1mL / min;

[0050] Detection wavelength: 230nm;

[0051] Column temperature: 30°C;

[0052] Injection volume: 20uL;

[0053] Wherein the mobile phase: Phosphate buffer and acetonitrile (adjust the pH value to 8.0 with phosphoric acid) is configured as the mobile phase according to the mass and number ratio of 57:43, wherein the concentration is 0.01mol / L The phosphate buffer is prepared in the following way: Take Dilute 1.3ml of lmol / L sodium dihydrogen phosphate solution and 32.5ml of 0.5mol / L disodium hydrogen phosphate solution to 1000ml with water and shake well.

[0054] Experimental steps:

[0055] Step 1: Solution preparation

[0056] System suitability solution: Take this product and impurit...

Embodiment 3

[0062] The instrument and setting conditions adopted in this embodiment:

[0063] High performance liquid chromatography: Shimadzu LC-20AT

[0064] Chromatographic column: Thermo Hypersil GOLD Dim.(mm) C18, 250mm×4.6mm, 5μm;

[0065] Flow rate of mobile phase: 1mL / min;

[0066] Detection wavelength: 230nm;

[0067] Column temperature: 30°C;

[0068] Injection volume: 20uL;

[0069] Wherein the mobile phase: Phosphate buffer and acetonitrile (adjust the pH value to 8.0 with phosphoric acid) is configured as the mobile phase according to the mass and number ratio of 59:41, wherein the concentration is 0.01mol / L The phosphate buffer is prepared in the following way: Take Dilute 1.3ml of lmol / L sodium dihydrogen phosphate solution and 32.5ml of 0.5mol / L disodium hydrogen phosphate solution to 1000ml with water and shake well.

[0070] Experimental steps:

[0071] Step 1: Solution preparation

[0072] System suitability solution: Take this product and impurities 2-(diethylbe...

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Abstract

The invention discloses an HPLC detection method for degradation impurities in lidocaine hydrochloride and a preparation thereof. The method comprises the steps of separating and determining the degradation impurities in lidocaine hydrochloride and the preparation thereof by using a high performance liquid chromatograph and adopting an isocratic elution method, wherein a chromatographic column with the detection wavelength of 230+ / -2nm takes octadecylsilane bonded silica gel as a filler, a mixed solution composed of a 0.01 mol / L phosphate buffer solution with a volume percentage of 50 to 60% and an organic phase with a volume percentage of 40 to 50% is used as a mobile phase, and the pH value of the organic phase is adjusted to 8.0 with phosphoric acid. The method disclosed by the invention has the characteristics of good separation degree, simplicity, rapidness, strong specificity and high sensitivity, and can be used for carrying out quality control on degradation impurities possibly introduced in production and storage of lidocaine hydrochloride and the preparation thereof, so that the quality of the whole product and the clinical medication safety are ensured.

Description

technical field [0001] The invention relates to the technical field of medicine preparation and detection, in particular to an HPLC detection method for degraded impurities in lidocaine hydrochloride and its preparations. Background technique [0002] Lidocaine hydrochloride is an amide local anesthetic, absorbed into the blood or administered intravenously, and has obvious biphasic excitatory and inhibitory effects on the central nervous system. At low dose, this product can promote K+ outflow in cardiomyocytes, reduce myocardial self-discipline, and has anti-ventricular arrhythmia effect; at therapeutic dose, it has no effect on the electrical activity of cardiomyocytes, atrioventricular conduction and myocardial contraction. Obvious effect; further increase in blood concentration can cause cardiac conduction velocity to slow down, atrioventricular block, inhibit myocardial contractility and reduce cardiac output. The chemical structure of lidocaine hydrochloride is as fo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34G01N30/36G01N30/32G01N30/54
CPCG01N30/02G01N30/34G01N30/36G01N30/32G01N30/54G01N2030/324
Inventor 刘爽杨莉冯冰燕艾尼玩尔·买提库尔班项德琼郭彬谈宗华吴统选王晓
Owner TIANSHENG PHARMA GROUP
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