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Method for detecting diethylaminoethanol in procaine hydrochloride

A technology of diethylaminoethanol and procaine hydrochloride is applied in the directions of measuring devices, instruments, scientific instruments, etc., and can solve the problems of high acidity, small molecular weight of diethylaminoethanol, inability to perform analysis by ultraviolet detectors, etc. simple effect

Inactive Publication Date: 2019-08-02
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is currently no literature report on the detection of diethylaminoethanol in procaine hydrochloride, and diethylaminoethanol has a small molecular weight, high acidity, strong polarity, and no ultraviolet absorption, so it cannot be analyzed by using a high-performance liquid phase ultraviolet detector.

Method used

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  • Method for detecting diethylaminoethanol in procaine hydrochloride
  • Method for detecting diethylaminoethanol in procaine hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The method for the described detection of diethylaminoethanol in procaine hydrochloride, the steps are as follows:

[0026] Take an appropriate amount of procaine hydrochloride, accurately weighed, add water to dissolve and dilute to a solution with a concentration of 20 mg / mL, as the test solution.

[0027] Take an appropriate amount of diethylaminoethanol, weigh it accurately, add water to dissolve and dilute to a solution with a concentration of 0.2 mg / mL, and use it as the reference solution.

[0028] Take an appropriate amount of diethylaminoethanol, accurately weighed, add water to dissolve and dilute to a solution with a concentration of 20 mg / mL, and use it as the reference substance stock solution.

[0029] Take 10 μL of each of the above solutions and spot them on the same silica gel G plate respectively. Use a double-trough development tank, one tank with ammonia water and the other tank with developer, the development ratio is 95:6. Fumigated in steam to de...

Embodiment 2

[0033] Get 3 batches of procaine hydrochloride injection stock solution (20mg / mL), respectively as need testing solution.

[0034] The method for the described detection of diethylaminoethanol in procaine hydrochloride, the steps are as follows:

[0035] Take an appropriate amount of diethylaminoethanol, weigh it accurately, add water to dissolve and dilute to make solutions with concentrations of 0.1mg / mL, 0.2mg / mL, and 0.3mg / mL, respectively, as the reference solution.

[0036] Take 10 μL of each of the above solutions, and place them on the same silica gel G plate respectively. Use a double-trough development tank, one tank with ammonia water, and the other tank with developer. The development ratio is 90:6. Fumigated in steam to develop color.

[0037] Judgment of the result: if the spot in the test product shows the corresponding position of diethylaminoethanol, it should not be darker than the spot color of the reference substance.

[0038] The test results of diethyla...

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Abstract

The invention belongs to the technical field of pharmaceutical analysis and in particular relates to a method for detecting diethylaminoethanol in procaine hydrochloride. The method comprises the following steps: (1), preparing a test solution; to be specific, taking procaine hydrochloride, dissolving the procaine hydrochloride by using a solvent, and diluting the solution into a solution of 10 mg / mL to 50 mg / mL; (2), preparing a reference solution; to be specific, taking a diethylaminoethanol reference substance, dissolving the diethylaminoethanol reference substance by using a solvent, and carrying out dissolution to obtain a solution of 0.05mg / mL to 0.5mg / mL; (3), taking the test solution and the reference solution respectively, carrying out sample application on a same silica gel thinlayer plate, carrying out expansion at a saturate tank, and carrying out drying by cold air; (4), carrying out development; to be specific, carrying out fumigation and development in iodine vapor; and(5), carrying out result determination; to be specific, a spot of a corresponding position of diethylaminoethanol is displayed in a sample and the spot is compared with a reference substance spot color to avoid the deeper color. Therefore, the quality of procaine hydrochloride can be controlled effectively. The operation becomes simple, convenient, and rapid; no special detection instrument is needed; and economical and practical effects are good.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for detecting diethylaminoethanol in procaine hydrochloride. Background technique [0002] Procaine hydrochloride acts on peripheral nerves to produce a conduction block effect, relying on a concentration gradient to penetrate the nerve cell membrane in a diffuse manner, blocking sodium ion channels on the inside, increasing the excitability threshold of nerve cells, losing excitability and conduction, information Delivery is blocked with good local anesthesia. At present, the dosage forms on the domestic market include tablets, capsules, injections and oral liquids. [0003] Diethylaminoethanol is a starting material for the synthesis of procaine hydrochloride. During the placement of procaine hydrochloride, it may be hydrolyzed to generate diethylaminoethanol. Diethylaminoethanol is both a process impurity of procaine hydrochloride. Also degrades impurities. T...

Claims

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Application Information

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IPC IPC(8): G01N30/90
CPCG01N30/90
Inventor 宋彩香郑林静林德森王娜
Owner SHANDONG QIDU PHARMA
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