A detection method of ricazazole related substances

A related substance, epipiprazole technology, applied in the detection field of epipiprazole related substances, can solve the problems of ineffective separation, the degree of separation can not meet the methodological requirements, etc., achieve comprehensive determination, high degree of separation, accurate determination Effect

Active Publication Date: 2022-08-09
四川弘远药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN105399736A uses octadecylsilane bonded silica gel as a chromatographic column, mobile phase A is sodium octane sulfonate solution, mobile phase B is acetonitrile, detection wavelength is 290nm, flow rate is 1.0ml / min for linear gradient elution, The quinoline dimer can be detected, but the inventor repeated the method in the application to detect ebiprazole and its 6 related substances, only 5 impurities could be detected, and the peaks of the related substances overlapped with the peaks of the drug, This method cannot effectively separate ebiprazole and its related substances
CN107525877A discloses a chromatographic column with octadecylsilane bonded silica gel as filler, phosphate buffer as mobile phase A, mixed solvent of methanol and acetonitrile as mobile phase B, detection wavelength of 225nm, and flow rate of 1.0ml / min, using the gradient elution method to detect ebiprazole and its 6 related substances, but the inventor repeated the application conditions to detect ebiprazole and its 6 related substances, and the separation of related substances could not meet the methodological requirements

Method used

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  • A detection method of ricazazole related substances
  • A detection method of ricazazole related substances
  • A detection method of ricazazole related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0109] Example 1 system applicability experiment

[0110] 1. Instrument and conditions

[0111] Polarites: Inrtsilods-3C18 column (4.6 × 150mm, 3 μm)

[0112] Flow phase: flow phase A: 0.1 % methic acid-acetylene solution, flow phase B: 0.1 % methic acid -0.04 mol / L ammonium chloride solution

[0113] Flow velocity: 1.0ml / min

[0114] Pillar temperature: 35 ℃

[0115] Test wavelength: 254nm

[0116] Class gradient elution according to the table below:

[0117]

[0118]

[0119] 2. Operation steps

[0120] Precision is said to take Epipozozozozozozozozozozozozoli and impurities BPZ-8, BPZ-9, BPZ-16, BPZ-23, BPZ-20, BPZ-29 controlling products in an appropriate amount. 2 So 4 -Teonate-methanol-ice acetic acid (56: 33: 11: 1)] dissolved and quantitatively diluted into a hybrid solution of about 0.4 mg of intraoprazole 0.4 mg, BPZ impurities 0.8 μg each as the system's applicable solution, the precision amount of precision, the precision amount Take 20 μL into the liquid chromatog...

Embodiment 2

[0125] Example 2 Epiprazole Materials Acceleration Test (temperature 40 ℃ ± 2 ℃, relative humidity 75 % ± 5 %) Sample sample detection

[0126] 1. Instrument and conditions

[0127] Polarites: Inrtsilods-3C18 column (4.6 × 150mm, 3 μm)

[0128] Flow phase: flow phase A: acetylene solution, flow phase B: 0.04 mol / L ammonium chloride solution

[0129] Wave length: 254nm;

[0130] Flow speed: 1.0ml / min;

[0131] Pillar temperature: 35 ° C;

[0132] Sample quantity: 20ul;

[0133] See the table below:

[0134]

[0135] 2. Operation method: The precision is called the Ipupurazole raw material after the fixed period acceleration test, and placed in a 25ml quantum.Exclude the test solution of 0.5ml, set the 100ml measuring bottle, and use the diluent [0.02mol / lNA 2 So 4 -Teonate-methanol-ice acetic acid (56: 33: 11: 1)] dilute to the scale, as a sample solution, injects liquid chromatography, recorded chromatography.

[0136] 3. Detection results

[0137] See Figure 10 The 3rd peak (main...

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Abstract

The present invention provides a detection method of neprarazole -related substances. This method uses a chromatographic column with ectumanelsiline bonding silicone as a filler.The gradient elution measurement measurement is Pippibazole and its related substances.This method can effectively separate neprarazole with adjacent impurities and each impurities, and high separation, which can accurately detect Neplopicazole and its related substances, effectively solve neptorazole and its related substancesThe problem of separation and detection difficulties ensure the control of neptorazole.

Description

Technical field [0001] The present invention involves a detection method related to substances, which belongs to the field of drug analysis and chemistry. Background technique [0002] Brexpiprazole is a dopamine, part of the 5-HT1A receptor agonist, and 5-HT2A receptor antagonist compounds for severe depression and schizophrenia. The chemical name of Tetraraidazole is 7 (4-(4 benzene percove [B] ibne-4-basinhzide-1-base) butadoxine-1H-oline-2-ketone, molecular formula: C 25 H 27 N 3 O 2 S, molecular weight: 433.57, its chemical structure is: [0003] [0004] In the process of synthetic compounds, important intermediates and impurities may affect the purity and quality of the drug due to incomplete removal. These known intermediates and impurities, and the degradation products produced are related substances. Research on matter is one of the key projects in drug quality research, which affects the stability and safety of drugs. Therefore, it is necessary to strictly control th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 柯潇张伟
Owner 四川弘远药业有限公司
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