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Method for detecting related substances in imidafenacin

A detection method and related substance technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of certain risks in drug quality assessment, degradation products that have not been analyzed and detected, and impurities that are easily interfered by solvent peaks. Achieve the effect of good separation, more types and numbers of impurities, and avoid missed detection and less detection

Active Publication Date: 2019-07-30
NANJING HEALTHNICE MEDICAL TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there are few literature reports about the detection method of related substances in this product, or although there are patent reports, for example, CN103063795A and CN104614468A respectively disclose the use of high performance liquid phase determination of midanacin and related substances, but the number of impurities is The coverage of impurity spectrum is small, the key and important degradation products are not analyzed and detected, some impurities are easily interfered by solvent peaks, the impurities have poor retention ability and weak response in the reported chromatographic system, and the evaluation of drug quality has certain risk

Method used

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  • Method for detecting related substances in imidafenacin
  • Method for detecting related substances in imidafenacin
  • Method for detecting related substances in imidafenacin

Examples

Experimental program
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Effect test

Embodiment 1

[0044] High performance liquid chromatography conditions:

[0045] The chromatographic column is an octadecylsilane bonded silica gel column, the model is Inertsil ODS-3C18 (250×4.6mm, 5μm), and the phosphoric acid solution of sodium octane sulfonate (take 1.08g sodium octane sulfonate, add mass concentration Dissolve and dilute to 1000ml for 0.1% phosphoric acid solution, adjust the pH value to 2.8 with triethylamine) as mobile phase A, with acetonitrile as mobile phase B, gradient elution, flow velocity is 1.0ml / min, detection wavelength is 220nm, column The temperature was 25°C, and the injection volume was 100 μl. Solvent 1 is 70% acetonitrile water, and solvent 2 is a mixed solution of mobile phase A and mobile phase B with a volume ratio of 67:33.

[0046] The gradient elution program is: (1) in 0-40 minutes, the volume ratio of mobile phase A and mobile phase B changes gradually from 80:20 to 60:40 at a uniform speed; (2) in 40-50 minutes, mobile phase A and mobile pha...

Embodiment 2

[0051] High performance liquid chromatography conditions:

[0052] The chromatographic column is an octadecylsilane bonded silica gel column, the model is Inertsil ODS-3C18 (250×4.6mm, 5μm), and the phosphoric acid solution of sodium octane sulfonate (take 1.08g sodium octane sulfonate, add mass concentration Dissolve and dilute to 1000ml for 0.1% phosphoric acid solution, adjust the pH value to 2.8 with triethylamine) as mobile phase A, with acetonitrile as mobile phase B, gradient elution, flow velocity is 1.0ml / min, detection wavelength is 220nm, column The temperature was 25°C, and the injection volume was 50 μl. Solvent 1 is 70% acetonitrile water, and solvent 2 is a mixed solution of mobile phase A and mobile phase B with a volume ratio of 67:33.

[0053] The gradient elution program is: (1) in 0-40 minutes, the volume ratio of mobile phase A and mobile phase B changes gradually from 80:20 to 60:40 at a uniform speed; (2) in 40-50 minutes, mobile phase A and mobile phas...

Embodiment 3

[0118] High performance liquid chromatography conditions:

[0119] The chromatographic column is an octadecylsilane bonded silica gel column, the model is Inertsil ODS-3C18 (250×4.6mm, 5μm), and the phosphoric acid solution of sodium octane sulfonate (take 1.08g sodium octane sulfonate, add mass concentration Dissolve and dilute to 1000ml for 0.1% phosphoric acid solution, adjust the pH value to 2.8 with triethylamine) as mobile phase A, with acetonitrile as mobile phase B, gradient elution, flow velocity is 1.0ml / min, detection wavelength is 218nm and 222nm, column temperature 25°C, injection volume 50μl. Solvent 1 is 70% acetonitrile water, and solvent 2 is a mixed solution of mobile phase A and mobile phase B with a volume ratio of 67:33.

[0120] The gradient elution program is: (1) in 0-40 minutes, the volume ratio of mobile phase A and mobile phase B changes gradually from 80:20 to 60:40 at a uniform speed; (2) in 40-50 minutes, mobile phase A and mobile phase B The vo...

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Abstract

The invention belongs to the technical field of chemical drug analysis and particularly relates to an analysis method for detecting related substances in imidafenacin. The detection method adopts highperformance liquid chromatography and comprises the chromatography condition that a flowing phase A and a flowing phase B are adopted as a mixed flowing phase for gradient elution, wherein the flowing phase A adopts a phosphoric acid solution of sodium 1-octanesulfonate; and the flowing phase B adopts acetonitrile. By adopting the detection method, detected impurities are numerous, the retainingability of main components and all the impurities in a flowing phase system is high, response is high, all the impurities can be separated effectively, and the related substances in the imidafenacin can be monitored rapidly and accurately.

Description

technical field [0001] The invention belongs to the technical field of chemical drug analysis, and in particular relates to an analysis method for detecting related substances in midanacin. Background technique [0002] Imidafenacin is a new type of diphenylbutyramide anticholinergic drug jointly developed by Japan Kyorin Pharmaceutical Co., Ltd. and Ono Pharmaceutical Co., Ltd. It has high bladder selectivity and is used for urinary urgency caused by overactive bladder, The treatment of a series of overactive bladder such as frequent urination and urinary incontinence was launched in Japan in June 2007. [0003] Overactive bladder is a syndrome characterized by symptoms of urinary urgency, often accompanied by frequency and nocturia, with or without urge incontinence. Detrusor instability is one of the important causes of overactive bladder. Midanacine selectively acts on the M3 and M1 receptors on the detrusor muscle, blocks the contraction effect of choline on the detru...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 宋晓庆吴锦萍王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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