Method for simultaneously determining contents of pregabalin and hydroxybenzene ester bacteriostatic agent

A technique of pregabalin, determination method, applied in the directions of measuring devices, instruments, scientific instruments, etc.

Active Publication Date: 2020-10-30
ACADEMY OF MILITARY MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] There is no documented method for simultaneously determining the content of pr

Method used

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  • Method for simultaneously determining contents of pregabalin and hydroxybenzene ester bacteriostatic agent
  • Method for simultaneously determining contents of pregabalin and hydroxybenzene ester bacteriostatic agent
  • Method for simultaneously determining contents of pregabalin and hydroxybenzene ester bacteriostatic agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] Embodiment 1: detection method example

[0080] 1. Experimental samples

[0081] Sample stock solution: take appropriate amount of pregabalin, methyl paraben, and propyl paraben reference substance, weigh them accurately, and dilute them to contain about 20 mg of pregabalin, 130 μg of methyl paraben, and 15 μg of propyl paraben in each 1 ml. The solution, shake well, respectively as the reference substance stock solution; wherein, pregabalin diluted with pure water, paraben antibacterial agents diluted with methanol.

[0082] System suitability test solution: Take 1ml of each of the above stock solutions, put them in a 10ml measuring bottle, dilute to the mark with mobile phase A, shake well, and use it as a system suitability solution.

[0083] Blank solution: mobile phase A.

[0084] Pregabalin (EP, lot number: 2.0, purity 99.7%), methylparaben (Acstandard, lot number: 17528-01 purity 97.5%), propylparaben (Acstandard, lot number: A008525301-02 purity 99.3%).

[...

Embodiment 2

[0099] Example 2: Specificity Verification

[0100] Prepare blank auxiliary material solution (not containing pregabalin, hydroxyphenyl ester bacteriostatic agent), measure above-mentioned blank auxiliary material solution 1ml, dilute mobile phase A to 10ml, inject sample according to embodiment 1 chromatographic conditions, the result sees image 3 . Wherein the blank auxiliary material solution is an aqueous solution containing an appropriate amount of sodium dihydrogen phosphate, anhydrous disodium hydrogen phosphate, sucralose and strawberry essence.

[0101] figure 2 The peak positions of pregabalin and hydroxybenzoate antibacterial agents in figure 1 blank solvent and image 3 There is no chromatographic peak at the corresponding position of the auxiliary material solution, that is, there is no interference. Depend on Figure 1-Figure 3 It can be seen that the blank solvent and blank excipient solution did not interfere with the detection of the content of pregab...

Embodiment 3

[0102] Embodiment 3: linearity test

[0103] Pregabalin API (India Sun Pharmaceutical Co., Ltd., batch number: PRVNF18053), methylparaben (Jiangxi Alpha Hi-Tech Pharmaceutical Co., Ltd., batch number: 20180701), propylparaben (Hunan Erkang Pharmaceutical Co., Ltd., batch number : 11072010401)

[0104] Accurately weigh 2000.89mg of pregabalin bulk drug, put it in a 100ml volumetric flask, add purified water to dissolve and dilute to the mark, and use it as pregabalin stock solution; accurately weigh 130.42mg of methylparaben, put it in a 100ml volumetric flask, add Dissolve in methanol and dilute to the mark as the methyl paraben stock solution; accurately weigh 16.34 mg of the propyl paraben and put it in a 100ml volumetric flask, add methanol to dissolve and dilute to the mark as the propyl paraben stock solution. Accurately measure 1, 1.5, 2, 3, and 4 mL of pregabalin stock solution and place them in 20 mL volumetric flasks, respectively, add 1, 1.5, 2, 3, and 4 mL of hyd...

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Abstract

The invention belongs to the field of medicines, and relates to a method for determining the content of pregabalin and a hydroxybenzene ester bacteriostatic agent. Specifically, the invention relatesto the method for simultaneously determining the pregabalin content and the hydroxybenzene ester bacteriostatic agent content in a pregabalin oral solution. The method is an HPLC method, and HPLC conditions are as follows: a chromatographic column is an octadecylsilane chemically bonded silica column; the column temperature is 20 to 40 DEG C; the mobile phase A is a 20 to 30 mmol/L monopotassium phosphate solution, and the pH value is 6.2 to 7.0; the mobile phase B is methanol; the flow rate is 0.5 to 1.5 mL/min; the sample size is 10 to 30 [mu] L; and the detection wavelength 210 nm. The method disclosed by the invention is good in specificity, high in sensitivity, good in repeatability and high in accuracy, and can be used for controlling the quality of the pregabalin oral solution.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a method for determining the content of pregabalin and parabens antibacterial agents in pregabalin oral solution, in particular, relates to a method for simultaneously determining the content of pregabalin in pregabalin oral solution and Methods for the content of paraben antibacterial agents. Background technique [0002] Pregabalin is a γ-aminobutyric acid (GABA) receptor agonist, which is commonly used clinically to treat neuropathic pain such as herpes zoster neuralgia, fibromyalgia syndrome, and partial incomplete seizures in adult patients. , Generalized anxiety disorder and other diseases. Lyrica (pregabalin) is one of the best-selling analgesics in the world, FDA approved for the treatment of neuralgia associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuralgia associated with spinal cord injury, neuralgia associated with fibromyalgia and Partial seizures in ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N2030/324
Inventor 郑爱萍王增明李静如钱好高静张慧
Owner ACADEMY OF MILITARY MEDICAL SCI
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