Method for analyzing lamotrigine by high performance liquid chromatography

A high-performance liquid chromatography and lamotrigine technology, applied in the field of drug analysis, can solve the problems of emphasizing process impurities or degrading impurities, affecting the accuracy of impurities, and clogging the liquid phase system, so as to achieve short running time, cost saving, and baseline gentle effect

Pending Publication Date: 2021-07-23
SANJIN GROUP HUNAN SANJIN PHARMA
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Problems solved by technology

Disadvantages: Two different chromatographic systems are used to measure the related impurities respectively. Lamotrigine and adjacent impurities can be separated well, but the baseline of the gradient operation of this method has large fluctuations, and the gradient baseline changes greatly Where there are impurities peaking, which will affect the accuracy of the impurity detection
"United States Pharmacopoeia" (USP38/USP40/USP43) adopts different liquid phase detection methods for the related substances of lamotrigine raw materials and tablets. Effective detection of process impurities and degradation impurities related to lamotrigine
Huang Nuozhe et al. (Determination of related substances in lamotrigine by HPLC. Journal of Drug Analysis 2020; 40(03):495-501.) Referring to the detection method of lamotrigine in the EP9.0 Pharmacopoeia, the two liquid phases The method is combined into a liquid-phase method. Although it can detect impurity B, impurity C, and impurity D at the same time, the separation degree of impurity G and a certain oxidative degradation impurity is not ideal, and the process impurities 2,3-

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  • Method for analyzing lamotrigine by high performance liquid chromatography
  • Method for analyzing lamotrigine by high performance liquid chromatography
  • Method for analyzing lamotrigine by high performance liquid chromatography

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Example Embodiment

[0027] Chromatographic conditions

[0028] In a typical embodiment of the invention, the chromatographic conditions are:

[0029] Columns: octadecyl silicone bilinen gel column, 4.6 × 250 mm, 5 μm;

[0030] Mobile phase A: methanol;

[0031] Mobile phase B: Regulate the pH of 0.5% triethylamine solution with phosphoric acid to 4.5;

[0032] Flow rate: 0.8 mL / min;

[0033] Wavelength: wavelength, 230 nm;

[0034] Column temperature: 40 ° C;

[0035] Number of injections: 20μL;

[0036] Gradient program: Table 2.

[0037]

[0038] Preparation of test products and control solution

[0039] To prepare a solution solution and a control solution, the dilution used in the examples of the present invention is a methanol-0.1 mol / L hydrochloric acid solution (20:80) mixed solution. The test showed that the dilution of the dilution was also stable at room temperature for 24 hours.

[0040] To prepare a solution solution, the right amount of the Lamo triazine preparation powder (about...

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Abstract

The invention provides a method for analyzing lamotrigine related substances by high performance liquid chromatography, which adopts a reversed-phase high performance liquid chromatographic column, takes octadecylsilane chemically bonded silica as a chromatographic column filler, takes methanol as a mobile phase A, takes a 0.2-0.8% triethylamine solution with the pH value of 4.2-5.0 as a mobile phase B, and adopts gradient elution. The method disclosed by the invention can be used for simultaneously detecting process impurities and degradation impurities related to lamotrigine, is relatively short in operation time, relatively smooth in base line and ideal in separation degree of main components and various impurities, and has relatively good specificity, stability and accuracy.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for evaluating the quality of drugs by high performance liquid chromatography. Background technique [0002] Lamotrigine is a broad-spectrum antiepileptic drug of the phenyltriazine class, which is suitable for the first-line treatment of epilepsy in children over 12 years old and adults. It was first launched in Ireland in 1990 and launched in China in 2007. [0003] During the synthesis and storage of lamotrigine, various process impurities and degradation impurities will be produced, see Table 1 for details. [0004] Table 1 Known impurities of lamotrigine [0005] [0006] [0007] The related substances of lamotrigine in European Pharmacopoeia (EP8.0 / EP9.0 / EP10.3 version) are the same as the related substances of lamotrigine in British Pharmacopoeia (BP2017 / BP2018 / 2021 version). Disadvantages: Two different chromatographic systems are used to measure the related...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8634G01N2030/047
Inventor 陈俊姜金生陈开义胡杰
Owner SANJIN GROUP HUNAN SANJIN PHARMA
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