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Method for separating and determining dextromethorphan and levomethorphan by liquid chromatography

A technology of dextromethorphan and high-performance liquid chromatography, which is applied in the field of drug analysis, can solve the problems of ineffective separation and analysis of dextromethorphan and dextromethorphan, low resolution, low linear range, etc., to ensure quality controllability , good repeatability and high precision

Pending Publication Date: 2020-06-23
GUANGDONG HUANAN PHARMACEUTICAL GROUP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the inventors found that this method cannot effectively separate and analyze dextromethorphan and dextromethorphan under the condition of high concentration of dextromethorphan, the linear range is low, and the degree of separation is not high

Method used

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  • Method for separating and determining dextromethorphan and levomethorphan by liquid chromatography
  • Method for separating and determining dextromethorphan and levomethorphan by liquid chromatography
  • Method for separating and determining dextromethorphan and levomethorphan by liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Instrument: Shimadzu LC-2030C 3D;

[0047] Chromatographic column: Philomon Chiral MJ (2) 5μ (4.6mm×250mm, 5μm)

[0048] Mobile phase: n-hexane-ethanol-diethylamine (90:10:0.1, V / V / V)

[0049] Column temperature: 30°C;

[0050] Flow rate: 0.5mL / min;

[0051] Detection wavelength: 285nm;

[0052] Preparation of mobile phase:

[0053] Mobile phase A: Measure 1000ml of ethanol, add 1ml of diethylamine, mix well, and get it;

[0054] Mobile phase B: Measure 1000ml of n-hexane, add 1ml of diethylamine, mix well, and get it;

[0055] Preparation of positioning solution:

[0056] Preparation of dextromethorphan positioning solution: accurately weigh 10 mg of dextromethorphan hydrobromide reference substance, put it in a 100ml measuring bottle, add diluent (n-hexane: ethanol: diethylamine=90: 10: 0.1, V / V / V) Dissolve and dilute to the mark, shake well, as dextromethorphan stock solution; accurately measure 1ml of dextromethorphan stock solution, put in 100ml measuring b...

Embodiment 2

[0061] Instrument: Shimadzu LC-2030C 3D;

[0062] Chromatographic column: Philomon Chiral MJ (2) 5μ (4.6mm×250mm, 5μm)

[0063] Mobile phase: n-hexane-ethanol-diethylamine (88:12:0.1, V / V / V)

[0064] Column temperature: 30°C;

[0065] Flow rate: 0.5mL / min;

[0066] Detection wavelength: 285nm;

[0067] Preparation of mobile phase:

[0068] Mobile phase A: Measure 1000ml of ethanol, add 1ml of diethylamine, mix well, and get it;

[0069] Mobile phase B: Measure 1000ml of n-hexane, add 1ml of diethylamine, mix well, and get it;

[0070] Preparation of positioning solution:

[0071] Preparation of dextromethorphan positioning solution: accurately weigh 10 mg of dextromethorphan hydrobromide reference substance, put it in a 100ml measuring bottle, add diluent (n-hexane: ethanol: diethylamine=88: 12: 0.1, V / V / V) Dissolve and dilute to the mark, shake well, as dextromethorphan stock solution; accurately measure 1ml of dextromethorphan stock solution, put in 100ml measuring b...

Embodiment 3

[0076] Instrument: Shimadzu LC-2030C 3D;

[0077] Chromatographic column: Philomon Chiral MJ (2) 5μ (4.6mm×250mm, 5μm)

[0078] Mobile phase: n-hexane-ethanol-diethylamine (95:5:0.1, V / V / V)

[0079] Column temperature: 30°C;

[0080] Flow rate: 0.5mL / min;

[0081] Detection wavelength: 285nm;

[0082] Preparation of mobile phase:

[0083] Mobile phase A: Measure 1000ml of ethanol, add 1ml of diethylamine, mix well, and get it;

[0084] Mobile phase B: Measure 1000ml of n-hexane, add 1ml of diethylamine, mix well, and get it;

[0085] Preparation of positioning solution:

[0086] Preparation of dextromethorphan positioning solution: accurately weigh 10 mg of dextromethorphan hydrobromide reference substance, put it in a 100ml measuring bottle, add diluent (n-hexane: ethanol: diethylamine=95: 5: 0.1, V / V / V) Dissolve and dilute to the mark, shake well, as dextromethorphan stock solution; accurately measure 1ml of dextromethorphan stock solution, put in 100ml measuring bot...

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Abstract

The invention relates to a method for separating and determining dextromethorphan and levomethorphan by liquid chromatography. The invention discloses a method for determining dextromethorphan and levomethorphan through high performance liquid chromatography. According to the determination method, a chromatographic column with silica gel coated with cellulose-tri (4-methyl benzoate) on the surfaceas a filler is adopted; detection conditions are as follows: detection conditions are as follows; chromatographic conditions: chromatographic conditions: wherein a chromatographic column is phenanthroline Chiral MJ (2) 5 mu (4.6 mm * 250 mm, 5 [mu)m), n-hexane-ethanol-diethylamine is used as a mobile phase for elution, the specific ratio of n-hexane to ethanol to diethylamine is 90: 10: 0.1, thedetection wavelength is 285 nm, the column temperature is 30 DEG C, and the mobile phase speed is 0.5 mL / min. The method disclosed by the invention is high in precision, good in repeatability and highin recovery rate, and can be widely applied to quality detection of dextromethorphan bulk drugs from different sources and corresponding preparations of dextromethorphan bulk drugs.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for separating and measuring dextromethorphan and dextromethorphan through high-performance liquid chromatography. Background technique [0002] Dextromethorphan is the dextro-isomer of morphine levomorphan methyl ether, which exerts central antitussive effect by inhibiting the medullary cough center. Its antitussive strength is equal to or slightly stronger than codeine. No analgesic effect, no tolerance and addiction in long-term application. Therapeutic doses do not inhibit respiration. Oral absorption is good, it takes 15-30 minutes to take effect, and the effect can be maintained for 3-6 hours. The concentration of the original drug in the plasma is very low. The chemical name of dextromethorphan is 3-methoxy-17-methyl-(9α,13α,14α)morphinan (3-methoxy-17-methyl-(9α,13α,14α)-Morphinan). [0003] The levoisomer of dextromethorphan (levomethorphan) is a central analges...

Claims

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Application Information

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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8809
Inventor 江璐琳赵用强顾云
Owner GUANGDONG HUANAN PHARMACEUTICAL GROUP CO LTD
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