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Method for measuring entacapone tablet dissolution rate through utilization of high performance liquid chromatography

A technology of high performance liquid chromatography and entacapone, which is applied in the field of high performance liquid chromatography to determine the dissolution rate of entacapone tablets, can solve the problems of limited accuracy, cumbersome operation and the like, and achieve the effect of efficient evaluation

Active Publication Date: 2019-11-12
聊城高新生物技术有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, this method is cumbersome and has limited accuracy.

Method used

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  • Method for measuring entacapone tablet dissolution rate through utilization of high performance liquid chromatography
  • Method for measuring entacapone tablet dissolution rate through utilization of high performance liquid chromatography
  • Method for measuring entacapone tablet dissolution rate through utilization of high performance liquid chromatography

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Chromatographic condition selection:

[0024] Diluent: Phosphate buffer solution with pH=5.5; Buffer: 2.1g / L sodium dihydrogen phosphate solution, adjust pH to 2.1 with phosphoric acid; Mobile phase: methanol, tetrahydrofuran, buffer solution=60:2:38; Wavelength: UV 300nm; Chromatographic column: 4.6mm*250mm; 5μm phenyl column; Column temperature: 30°C; Flow rate: 1.0ml / min; Injection volume: 10μl.

[0025] Specificity experiment of the present invention: enter blank solvent, blank auxiliary material, reference substance solution, and test product solution respectively to investigate the specificity of the method, and confirm that the blank solvent and auxiliary materials of this verification method do not interfere with the determination of entacapone.

[0026] The solution was prepared as follows:

[0027] Blank solvent: phosphate solution with pH=5.5: 6.8g / l potassium dihydrogen phosphate solution, adjust the pH to 5.5 with 0.5M sodium hydroxide.

[0028] Blank exc...

Embodiment 2

[0034] Linear correlation experiment of the inventive method

[0035] Take about 20 mg of entacapone reference substance, accurately weigh it, put it in a 25ml measuring bottle, add 20% methanol, and ultrasonically dissolve it, then add a certain amount of medium to dilute and set the volume to the mark, as a stock solution.

[0036] Accurately measure 1ml, 2ml, 3ml, and 5ml of the above-mentioned stock solution respectively, put them in a 20ml measuring bottle, add dissolution medium to dissolve and dilute to the scale, and prepare solutions with concentrations of 20%, 40%, 60%, and 100%; Put 2ml and 3ml of the stock solution into 10ml measuring bottles respectively, add dissolution medium to dissolve and dilute to the mark, and prepare 80% and 120% concentration solutions.

[0037] Analyze according to the detection method of the present invention, the injection volume is 10 μ l, take the concentration of entacapone as the abscissa, and the peak area as the ordinate to make ...

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Abstract

The invention provides a method for measuring an entacapone tablet dissolution rate through utilization of high performance liquid chromatography. An ultraviolet detector is employed and elution is carried out through utilization of reversed-phase high performance liquid chromatography. A sample solution and a standard solution are prepared through utilization of a dissolution apparatus. The sample solution and the standard solution are injected into a chromatograph, and chromatograms are recorded. Computing is carried out based on a peak area according to an external standard method, and theentacapone tablet dissolution rate is measured. According to the method, the vacancy that no analysis method for measuring the entacapone tablet dissolution rate through utilization of the high performance liquid chromatography exists at present is filled up, research, development and production requirements can be satisfied, and relatively strict and effective control over the entacapone tablet dissolution rate can be carried out.

Description

technical field [0001] The invention belongs to the technical field of drug testing, and in particular relates to a method for measuring the dissolution rate of entacapone tablets by high performance liquid chromatography. Background technique [0002] Entacapone is a new class of drug for the treatment of Parkinson's disease that has been pushed into the clinic after levodopa and dopamine receptor agonists. It can inhibit the activity of peripheral catechol-O-methyltransferase (COMT) and prolong the The half-life of levodopa and the area under the drug-time curve can prolong and increase the bioavailability of levodopa, but it does not affect the peak time and peak concentration. important adjuvant drugs. Entacapone tablets are considered to be a relatively safe inhibitor of peripheral catechol-O-methyltransferase. Dissolution is often used as an important indicator for evaluating the quality of drugs. The method for determining the dissolution of entacapone tablets is re...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 韩军张勤秀王正平
Owner 聊城高新生物技术有限公司
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