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Separation and determination method of erlotinib hydrochloride and potential impurities

An erlotinib hydrochloride, a potential technology, applied in the direction of material separation, measuring device, analysis material, etc., can solve the problem of not simultaneously separating and measuring erlotinib hydrochloride, etc., achieve high sensitivity, ensure product quality, and strong specificity Effect

Active Publication Date: 2021-06-01
CHONGQING HUABANGSHENGKAI PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no HPLC method for the simultaneous separation and determination of erlotinib hydrochloride and the above 10 potential impurities

Method used

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  • Separation and determination method of erlotinib hydrochloride and potential impurities
  • Separation and determination method of erlotinib hydrochloride and potential impurities
  • Separation and determination method of erlotinib hydrochloride and potential impurities

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099] 1. Instruments and conditions

[0100] Instrument: high performance liquid chromatography;

[0101] Chromatographic column: Agilent Eclipse XDB C18 (4.6×250mm, 5μm);

[0102] Mobile phase: Carry out linear gradient elution as shown in Table 1;

[0103] A: Phosphate buffer salt (take 1.36g of potassium dihydrogen phosphate, add water to dissolve and dilute to 1000ml, add 2.0ml of diethylamine solution, mix well, adjust the pH value to 3.1±0.1 with phosphoric acid solution);

[0104] B: methanol-acetonitrile (volume ratio 1:1);

[0105] Table 1 Gradient elution table

[0106]

[0107] UV detector detection wavelength: 247nm;

[0108] Flow rate: 1.0ml / min;

[0109] Column temperature: 30°C;

[0110] Injection volume: 20μl;

[0111] Diluent: acetonitrile aqueous solution (volume ratio 1:1).

[0112] 2. Experimental steps

[0113] (1) Positioning solution of each impurity: Accurately weigh the appropriate amount of each impurity reference substance, put it in dif...

Embodiment 2

[0120] Embodiment 2 The method of the present invention and the comparison of existing analytical method

[0121] Erlotinib hydrochloride is not recorded in Ch.P, USP and EP, so refer to the related substance analysis method in the National Imported Drug Registration Standard JX20080202 of Erlotinib Hydrochloride Tablets (see Table 2 methods 1-3), but this The method does not control for known impurities.

[0122] Method 4 in Table 2 is the method recorded in the reference "Qualitative and Quantitative Analysis of 5 Related Substances in Erlotinib Hydrochloride and Its Tablets" [from "Journal of Pharmaceutical Analysis", Issue 5, 2015].

[0123] Method 5 in Table 2 is the method of the present invention.

[0124] Table 2 Analysis methods of related substances

[0125]

[0126]

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Abstract

The invention belongs to the field of analytical chemistry, and in particular relates to a separation and determination method for erlotinib hydrochloride and related potential impurities. The method uses octadecylsilane bonded silica gel as the stationary phase, and elutes with methanol-acetonitrile mixed solution and phosphate buffered saline as the mobile phase. Separation, this method can also use high performance liquid chromatography for separation and determination, not only to achieve effective separation, but also to accurately determine the content of erlotinib hydrochloride and related potential impurities, with strong specificity and high sensitivity. The quality control and safety assurance of lotinib are of great significance.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a separation and determination method for erlotinib hydrochloride and related potential impurities. Background technique [0002] Erlotinib hydrochloride is a tyrosine kinase inhibitor, suitable for locally advanced or metastatic non-small cell lung cancer after failure of at least one chemotherapy regimen. The Chinese name of Erlotinib hydrochloride is: N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinolineamine hydrochloride, and the English name is: Erlotinib hydrochloride , and its structural formula is shown in Formula I: [0003] [0004] In the synthetic process of erlotinib hydrochloride, the raw materials K and J used in its synthesis, and the synthetic process produce by-products A, B, D, E, F, G, H, I, which all make the final obtained erlotinib hydrochloride The impurities contained in lotinib, the structural formulas of these related potential i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88G01N30/06
CPCG01N30/06G01N30/88G01N2030/884
Inventor 周春燕杨婧夏爽
Owner CHONGQING HUABANGSHENGKAI PHARM
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