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A kind of analysis method of neuromuscular blocking agent

A separation method, the technology of mivacurium chloride, applied in the field of analysis of neuromuscular blocking agents, can solve the problems of drug safety and effectiveness threats, and achieve the effect of mild conditions

Active Publication Date: 2021-11-09
SICHUAN CREDIT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the chromatographic conditions cannot effectively detect the presence and content of potential impurities, it will pose a great threat to the safety and effectiveness of the drug
[0010] At present, there is no report on the effective analysis and detection method of mivacurium chloride to the above-mentioned impurities of known structure and impurities of unknown structure

Method used

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  • A kind of analysis method of neuromuscular blocking agent
  • A kind of analysis method of neuromuscular blocking agent
  • A kind of analysis method of neuromuscular blocking agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Main experimental equipment and chromatographic conditions:

[0074] Waters e2695 high performance liquid chromatograph is used, equipped with waters2695 separation unit, 2489 ultraviolet-visible light detector, and the chromatographic analysis and processing system adopts Empower chromatographic workstation.

[0075] Chromatographic conditions:

[0076] Chromatographic column: Octadecylsilane bonded silica gel column

[0077] Mobile phase: Mobile phase A: 0.005mol / L ammonium dihydrogen phosphate (adjust the pH to 5.9 with ammonia water)-acetonitrile (85:15)

[0078] Mobile phase B: water-acetonitrile (5:95)

[0079] Gradient elution:

[0080]

[0081] Wavelength: 275nm

[0082] Flow rate: 0.5mL / min

[0083] Column temperature: 50°C

[0084] Injection volume: 20μL

[0085] System suitability solution: Weigh the mivacurium chloride sample, and prepare a mixed solution containing mivacurium chloride and impurities A, B, C, and D as the system suitability solutio...

Embodiment 2

[0093] Main experimental equipment and chromatographic conditions:

[0094] Waters e2695 high performance liquid chromatograph is used, equipped with waters2695 separation unit, 2489 ultraviolet-visible light detector, and the chromatographic analysis and processing system adopts Empower chromatographic workstation.

[0095] Chromatographic conditions:

[0096] Chromatographic column: Octadecylsilane bonded silica gel column

[0097] Mobile Phase: Mobile Phase A: Water-Acetonitrile (75:25)

[0098] Mobile phase B: 0.1mol / L sodium dihydrogen phosphate (adjust pH to 2.0 with phosphoric acid)-acetonitrile (10:90)

[0099] Gradient elution:

[0100]

[0101]

[0102] Wavelength: 260nm

[0103] Flow rate: 1.3mL / min

[0104] Column temperature: 55°C

[0105] Injection volume: 20μL

[0106] System suitability solution: Weigh the mivacurium chloride sample, and prepare a mixed solution containing mivacurium chloride and impurities A, B, C, and D as the system suitability ...

Embodiment 3

[0114] Main experimental equipment and chromatographic conditions:

[0115] Waters e2695 high performance liquid chromatograph is used, equipped with waters2695 separation unit, 2489 ultraviolet-visible light detector, and the chromatographic analysis and processing system adopts Empower chromatographic workstation.

[0116] Chromatographic conditions:

[0117] Chromatographic column: Octadecylsilane bonded silica gel column

[0118] Mobile phase: Mobile phase A: 0.3mol / L sodium acetate (adjust the pH to 5.2 with ammonia water)-methanol (95:5)

[0119] Mobile Phase B: Water-Methanol (25:75)

[0120] Gradient elution:

[0121]

[0122]

[0123] Wavelength: 290nm

[0124]Flow rate: 1.0mL / min

[0125] Column temperature: 40°C

[0126] Injection volume: 20μL

[0127] System suitability solution: Weigh the mivacurium chloride sample, and prepare a mixed solution containing mivacurium chloride and impurities A, B, C, and D as the system suitability solution.

[0128] N...

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Abstract

An analytical method for a neuromuscular blocking agent, the method comprising the step of separating mivacurium chloride by high performance liquid chromatography, in the high performance liquid chromatography, octadecyl bonded silica gel is used as a fixed Phase, detection wavelength is 250~300nm, carry out gradient elution with mobile phase A and mobile phase B, wherein, described mobile phase A is aqueous solution: organic solvent=100:0~50:50 (v / v), mobile Phase B is aqueous solution:organic solvent=0:100~50:50 (v / v). The method of the present invention can effectively separate, detect, and quantitatively measure three isomers of mivacurium chloride, four known impurities and various other impurities, which is conducive to ensuring the drug safety and effectiveness of mivacurium chloride; and The method of the invention has mild conditions and has no strict requirements on high performance liquid chromatography instruments, analytical reagents and chromatographic columns.

Description

technical field [0001] The invention relates to a method for analyzing neuromuscular blocking agents. Background technique [0002] In anesthesia, neuromuscular blocking agents are used to provide skeletal muscle relaxation during surgery and intubation. Neuromuscular blocking agents are generally divided into two types: depolarizing and non-depolarizing according to the mechanism of action; according to the duration of action, they are divided into three types: short-acting, intermediate-acting, and long-acting. Depolarizing drugs include succinylcholine and decyldiamide, and because of their depolarizing mechanism of action, these drugs have serious side effects such as cardiac arrest and death, hyperkalemia, malignant hyperthermia, severe muscle pain, cardiac arrhythmia, Increased intraocular pressure and increased stomach tension, etc. Nondepolarizing neuromuscular blocking agents include long-acting agents such as d-tubocurarine, pancuronium, relaxin iodine, diallyl s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/047G01N2030/065
Inventor 蒋春霞廖丽萍傅霖陈刚李晓莉
Owner SICHUAN CREDIT PHARMA
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