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CDC7 inhibitor related substance detection method

A technology related to substances and detection methods, applied in the field of drug analysis, can solve problems such as the lack of detection methods, and achieve the effects of stable stability, simple operation and strong adaptability

Pending Publication Date: 2022-05-27
ZENJI RES LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there is no detection method for the above-mentioned related substances

Method used

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  • CDC7 inhibitor related substance detection method
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  • CDC7 inhibitor related substance detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1: specificity test.

[0037] The specificity test needs to verify that the blank solution has no interference at the retention time of the main peak in the test product and the reference solution and the resolution between impurities and the main component. The following is the preparation method of each impurity and main component:

[0038] Impurity A positioning solution: Accurately weigh 17.5 mg of the impurity A reference substance, add methanol: water (1:1) to a 50ml measuring bottle, ultrasonically dissolve and dilute to the volume, shake well, and use it as the impurity A stock solution; The impurity A stock solution was quantitatively diluted to make 17.5 μg / ml, which was used as the impurity A positioning solution.

[0039] Impurity B positioning solution: Accurately weigh 17.5mg of the impurity B reference substance, put it into a 50ml measuring bottle, add methanol: water (1:1) ultrasonically to dissolve and dilute to the volume, shake well, and ...

Embodiment 2

[0057] Embodiment 2: Sensitivity test.

[0058] Take the impurity B stock solution, impurity C stock solution, and reference substance solution prepared in Example 1 and dilute with a solvent to make a solution with a suitable concentration, dilute step by step to a suitable multiple, and use the solution when the signal-to-noise ratio ≥ 10:1 as the limit of quantitation Solution; the solution when the signal-to-noise ratio ≥ 3:1 is used as the detection limit solution.

[0059] Precisely measure 10 μl each of the limit of quantification solution and the limit of detection solution, and inject them into the liquid chromatograph.

[0060] Table 2 Quantitative limit verification results

[0061] name Concentrationμg / ml S / N Sensitivity (%) Impurity B 0.105540 22.0 0.03 CDC7 inhibitor 0.104796 11.3 0.03 Impurity C 0.095247 18.1 0.03

[0062] Table 3 Detection limit verification results

[0063] name Concentrationμg / ml S / ...

Embodiment 3

[0065] Embodiment 3: repeatability test

[0066] The test solution: take an appropriate amount of CDC7 inhibitor, weigh it accurately, add solvent to dissolve and dilute to make a solution containing 0.35mg per 1ml. Prepare 6 copies in parallel.

[0067] Accurately measure each 10 μl of the test solution respectively and inject it into a liquid chromatograph. The chromatographic conditions are the same as in Example 1. The results are shown in Table 4.

[0068] Table 4 Repeatability inspection results

[0069] Impurity No. 1 2 3 4 5 6 RSD(%) Impurity B 0.12 0.11 0.11 0.11 0.11 0.11 3.66 Impurity C 0.16 0.16 0.16 0.16 0.16 0.16 0.00 total miscellaneous 0.07 0.07 0.07 0.07 0.07 0.07 0.00

[0070] It can be seen from Table 4 that the RSD of single impurity content meets the requirements (the RSD of each impurity with a content of less than 0.5% is not greater than 10.0%; the RSD of each impurity with a content of 0.5% to...

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Abstract

The invention discloses a detection method of CDC7 inhibitor related substances, and belongs to the technical field of pharmaceutical analysis. The detection method comprises the following steps: (1) preparing a reference substance solution and a test solution; (2) detection: adopting a high performance liquid chromatography, using a mobile phase A as a 0.05%-0.5% acidic buffer solution, using a mobile phase B as an organic solvent, using a detection wavelength of 220-270 nm, and using the elution gradient mobile phase A according to the volume ratio of 0 min: 100%-90%, 0-25 min: 90%-50%, 25-35 min: 50%-5%, 35-40 min: 5%, and 40-48 min: 5%-90%; and (3) calculating the content of the related substances in the detection map in the step (2). According to the detection method, a specific CDC7 inhibitor detection method is established, the content of each related substance in the CDC7 inhibitor can be accurately detected, and the specificity, the sensitivity, the repeatability and the stability are good.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for detecting related substances of CDC7 inhibitors. Background technique [0002] Cancer is an uncontrolled proliferative disease in which most cancer cells proliferate at a higher rate than normal cells. During cell cycle division, chromosome replication is essential, and the replication of DNA in S phase is tightly regulated. Inhibition of DNA replication has been proven useful in cancer therapy, and its inhibitors have been widely used clinically, such as gemcitabine, an active metabolite of 5-fluorouracil, and Hydroxyurea (HU). [0003] CDC7 (cell division cycle 7) is a serine-threonine kinase that plays a key role in DNA synthesis and is required for activation of the DNA replication origin throughout the S phase of the cell cycle. The kinase activity of CDC7 is regulated by binding to its activating partner. During late G1 and S phases, CDC7 f...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/32G01N30/54
CPCG01N30/02G01N30/06G01N30/32G01N30/54G01N2030/324
Inventor 罗林张筱雯马燕赵惠婕
Owner ZENJI RES LAB
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