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Method for detecting rocuronium bromide intermediate and impurities

A detection method, technology of rocuronium bromide, applied in measuring devices, instruments, scientific instruments, etc.

Active Publication Date: 2022-02-25
JIANGSU LONG HEALTHCARE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there is no relevant literature at present to report the analysis and detection method of the above-mentioned intermediate and impurity, and the structure of the above-mentioned intermediate and the above-mentioned impurity is similar, so a simple, stable and effective analysis and detection method is established for this rocuronium bromide intermediate. It is very necessary to analyze and detect the body and impurities

Method used

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  • Method for detecting rocuronium bromide intermediate and impurities
  • Method for detecting rocuronium bromide intermediate and impurities
  • Method for detecting rocuronium bromide intermediate and impurities

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1 specificity test

[0035] Instrument: Thermo Ultimate 3000 high performance liquid chromatograph, diode array detector (DAD)

[0036] Column: Waters C18 (4.6mm×150mm, 3.5μm)

[0037] Column temperature: 35°C

[0038] Mobile phase: 20mmol / L ammonium carbonate solution (adjust the pH value to 10.4 with ammonia water) as mobile phase A, acetonitrile-tetrahydrofuran (9:1) as mobile phase B, perform gradient elution according to Table 1

[0039] Detection wavelength: 210nm

[0040]Flow rate: 1.0ml / min

[0041] Injection volume: 5μl

[0042] Table 1 Gradient elution program

[0043] time (minutes) Mobile phase A(%) Mobile phase B(%) 0.0 60.0 40.0 30.0 25.0 75.0 40.0 25.0 75.0 40.1 60.0 40.0 50.0 60.0 40.0

[0044] Diluent (blank solution) : Tetrahydrofuran.

[0045] Impurity localization solution preparation : Take impurity 1, impurity 2, impurity 3 and impurity 4 reference substances respectively, accur...

Embodiment 2

[0052] Embodiment 2: repeatability test

[0053] Preparation of the test solution : get rocuronium bromide intermediate test sample appropriate, accurately weighed, dissolve and dilute with tetrahydrofuran, make the solution that contains 20mg rocuronium bromide intermediate approximately in every 1ml, as need testing sample solution.

[0054] According to the step of above-mentioned need testing solution preparation, prepare 6 parts of rocuronium bromide intermediate concentration in parallel the solution that is 20mg / ml as need testing solution. According to the chromatographic conditions of Example 1, the repeatability of the sample quantitative detection was investigated, and the results are shown in Table 3.

[0055] Table 3 Rocuronium bromide intermediate and impurity repeatability test results

[0056]

[0057]

[0058] From the data in Table 3, it can be seen that the retention time of the main peak and the purity of the main peak have no significant change, a...

Embodiment 3

[0059] Embodiment 3: linearity test

[0060] Get the appropriate amount of rocuronium bromide intermediate reference substance and each impurity reference substance respectively, accurately weighed, add THF to dissolve and dilute, respectively make the rocuronium bromide intermediate relative concentration be embodiment 2 need testing solution concentration (20mg / ml) of 0.05%, 2%, 10%, 50%, 100% and 120%, that is, the concentrations are 0.0101mg / ml, 0.404mg / ml, 2.011mg / ml, 10.164mg / ml, 20.046mg / ml and 23.981 mg / ml solution. The prepared solutions were respectively injected into the liquid chromatograph according to the chromatographic conditions of Example 1, and the respective chromatograms were recorded. Draw a curve with the concentration as the abscissa and the peak area as the ordinate. The results are shown in Table 4.

[0061] Table 4 Rocuronium bromide intermediate linearity test result

[0062]

[0063] From the data in Table 4, it can be seen that the correla...

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Abstract

The invention provides a method for detecting a rocuronium bromide intermediate and impurities, which adopts a high performance liquid chromatography to detect and analyze the rocuronium bromide intermediate, an impurity 1, an impurity 2, an impurity 3 and an impurity 4. According to the method, known impurities can be accurately detected, the main peak of the intermediate and the peak of the known impurities can be effectively separated, and the method is a brand-new detection and analysis method beneficial to quality control of the rocuronium bromide intermediate. The method is high in sensitivity, wide in linear range, good in specificity and repeatability and easy and convenient to operate.

Description

technical field [0001] The invention relates to the technical field of drug detection and analysis, in particular to a method for detecting rocuronium bromide intermediates and impurities. Background technique [0002] Rocuronium Bromide, chemical name 1-[17β-(acetyloxy)-3α-(hydroxyl)-2β-(morpholin-4-yl)-5α-androstane-16β-yl] -1-(Propyl-2-enyl)pyrrolidine bromide, a non-depolarizing neuromuscular blocking agent, competitively binds to cholinergic receptors on motor nerve terminal synapses to antagonize The role of acetylcholine. Rocuronium bromide can be used as an adjuvant for general anesthesia for routine endotracheal intubation to relax skeletal muscles during surgery or mechanical respiration, so as to facilitate surgical operations and improve the body's gas exchange. It is suitable for general anesthesia and relaxes skeletal muscles and endotracheal tube. Rocuronium bromide is fast acting and generally provides excellent conditions for intubation within 60 seconds ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 史明敏罗林赵慧赵心怡祁智
Owner JIANGSU LONG HEALTHCARE
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