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Method for determining lidocaine hydrochloride related substances by high performance liquid chromatography

A high-performance liquid chromatography and lidocaine hydrochloride technology, which is applied in the field of high-performance liquid chromatography for the determination of lidocaine hydrochloride related substances, can solve problems such as difficulty in the determination of lidocaine hydrochloride substances, and achieves high reproducibility and specificity. Good, accurate and reliable results

Pending Publication Date: 2020-05-29
TIANJIN PHARMA GROUP XINZHENG
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] The purpose of the present invention is to solve the problem that the related substances of lidocaine hydrochloride are difficult to measure, and provide a method for the determination of related substances of lidocaine hydrochloride by high performance liquid chromatography. The method can detect more impurities, and through methodology Verification, accurate and reliable test results

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  • Method for determining lidocaine hydrochloride related substances by high performance liquid chromatography
  • Method for determining lidocaine hydrochloride related substances by high performance liquid chromatography
  • Method for determining lidocaine hydrochloride related substances by high performance liquid chromatography

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Embodiment 1

[0032] A method for the determination of lidocaine hydrochloride related substances by high performance liquid chromatography, the chromatographic conditions are as follows:

[0033] Octadecylsilane bonded silica gel with polar groups is selected as the stationary phase; the particle size of the chromatographic column is 5 μm; the detection wavelength: 225nm; the flow rate: 0.8ml / min; the column temperature: 30°C,

[0034] Mobile phase: in parts by mass, composed of 50ml 0.035mol / L phosphate buffer and 20ml organic solvent; the potassium dihydrogen phosphate solution is adjusted to pH 8.0 with 10% sodium hydroxide solution, and the detector used is High performance liquid chromatography.

Embodiment 2

[0036] A method for the determination of lidocaine hydrochloride related substances by high performance liquid chromatography, the chromatographic conditions are as follows:

[0037] Octadecylsilane bonded silica gel with polar groups is selected as the stationary phase; the particle size of the chromatographic column is 5 μm; the detection wavelength: 230nm; the flow rate: 1.0ml / min; the column temperature: 35°C, the mobile phase : In parts by mass, it is composed of 70ml0.035mol / L potassium dihydrogen phosphate solution and 30ml acetonitrile, and the detector used is a high performance liquid chromatograph.

Embodiment 3

[0039] A method for the determination of lidocaine hydrochloride related substances by high performance liquid chromatography, the chromatographic conditions are as follows:

[0040] Octadecylsilane bonded silica gel with polar groups is selected as the stationary phase; the particle size of the chromatographic column is 5 μm; the detection wavelength: 235nm; the flow rate: 1.2ml / min; the column temperature: 40°C,

[0041] Mobile phase: in parts by mass, composed of 80ml of 0.035mol / L phosphate buffer and 50ml of organic solvent; the detector used is a high performance liquid chromatograph.

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Abstract

The invention discloses a method for determining lidocaine hydrochloride related substances by high performance liquid chromatography, and relates to the field of drug detection, the chromatographic conditions are as follows: octadecylsilane chemically bonded silica bonded with polar groups is selected as a filler as a stationary phase; wherein the particle size of the chromatographic column is 5[mu]m, the detection wavelength ranges from 225 nm to 235 nm, the flow rate is 0.8 to 1.2 ml / min, the column temperature is 30-40 DEG C, and the mobile phase is prepared from the following componentsin parts by mass: 50-80 parts of 0.035 mol / L phosphate buffer solution and 20-50 parts of organic solvent. The adopted detector is a high performance liquid chromatograph, more impurities can be detected by the method, and methodological verification proves that the detection result is accurate and reliable.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for determining related substances of lidocaine hydrochloride by high performance liquid chromatography. Background technique [0002] Lidocaine Hydrochloride is an amide local anesthetic, mainly used for block anesthesia, epidural anesthesia, and also for antiarrhythmia. Related substances, also known as impurities, are mainly starting materials, intermediates, polymers, side reaction products, and degradation products during storage brought in during the production process. At present, lidocaine hydrochloride can be made into a variety of preparation forms, such as injections, mucilage, gel, etc., and the existing disclosed methods for the determination of related substances cannot realize the determination of related substances of lidocaine hydrochloride. In order to strictly control the drug quality, improve the safety of the drug, and reduce the harm to the human body...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/34G01N30/36G01N30/74G01N30/86
CPCG01N30/02G01N30/34G01N30/36G01N30/74G01N30/8679G01N2030/027
Inventor 李淑云周红建李俊霞白艳鹤
Owner TIANJIN PHARMA GROUP XINZHENG
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