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Methods for determining the content of imidafenacin and detecting related substances

A technology for Midanaxin and related substances, which is applied in the content determination of Midanaxin and the detection of related substances, can solve the problems of the content of raw materials and the analysis methods of related substances without literature reports, etc., and achieve good repeatability and recovery rate , content determination results are accurate and the effect of high precision

Active Publication Date: 2013-04-24
NANJING CORE TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the new dosage form of Midana that has been on the market is a tablet. However, due to data protection and other reasons, there is no literature report on the content of this raw material and the analysis method of related substances.

Method used

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  • Methods for determining the content of imidafenacin and detecting related substances
  • Methods for determining the content of imidafenacin and detecting related substances
  • Methods for determining the content of imidafenacin and detecting related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Example 1 The reversed-phase high-performance liquid chromatography determination of midanacin content

[0019] Chromatographic conditions and system adaptability: Octadecylsilane bonded silica gel was used as filler (Waters X-bridge 5μm 4.6×250mm), detection wavelength was 220nm, column temperature was 40°C, and flow rate was 1.0 mL / min. The mobile phase is acetonitrile: 20mmol / L disodium hydrogen phosphate (adjust the pH to 7.45 with phosphoric acid) = 37:63, and the theoretical plate should not be less than 3000.

[0020] Take an appropriate amount of about 10 mg of midanate sample, accurately weigh it, put it in a 50 mL measuring bottle, add solvent (acetonitrile: 20 mmol / L disodium hydrogen phosphate solution (adjust pH to 7.45 with phosphoric acid) volume ratio = 1:1) dissolve and dilute to the scale, shake well, accurately measure 1mL to 10mL volumetric flask, add solvent to dissolve and dilute to the scale, as the test solution; another appropriate amount of ref...

Embodiment 2

[0039] Example 2 The reversed-phase high-performance liquid chromatography determination of related substances of midanacin

[0040] Chromatographic conditions and system adaptability: Octadecylsilane bonded silica gel was used as filler (Waters X-bridge 5μm 4.6×250mm), detection wavelength was 220nm, column temperature was 40°C, and flow rate was 1.0 mL / min. The mobile phase is phase A: 20mmol / L disodium hydrogen phosphate (adjust the pH to 7.45 with phosphoric acid), phase B: acetonitrile, the gradient program is shown in the table below, and the theoretical plate should not be less than 3000. Gradient elution was carried out according to the following mobile phase conditions:

[0041] time (minutes)

mobile phase A

mobile phase B

0

65

35

10

65

35

15

20

80

25

20

80

35

65

35

[0042] The following items related to the detection method of the substance have been verified:

[004...

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Abstract

The present invention discloses methods for determining the content of imidafenacin and detecting related substances. According to the methods, high-performance liquid chromatography is mainly used for determining and detecting the content of active pharmaceutical ingredient imidafenacin, and imidafenacin related substances. The methods are time-saving and labor-saving, high in precision, accurate in content determination results, and good in repeatability and recovery, and the method is validated, and can be used for routine analysis and quality control of imidafenacin materials and preparation samples.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular, relates to a quality control method of midanacin bulk drug, in particular to a method for determining the content of midanacin and detecting related substances. Background technique [0002] Mida new, English name imidafenacin, chemical name 4-(4-methyl-1H-imidazol-1-yl)-2,2-diphenylbutyramide (4-(2-methyl-1H-imidazol-1 -yl)-2,2-dipheybutanamide). Midanacin is a new type of diphenylbutyramide anticholinergic drug jointly developed by Japan Ono Pharmaceutical Co., Ltd. and Kyorin Pharmaceutical Co., Ltd. It has high bladder selectivity and is used for the treatment of overactive bladder. It was launched in Japan in June 2007 . [0003] Overactive Bladder (OAB) 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. T...

Claims

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Application Information

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IPC IPC(8): G01N30/89
Inventor 王雪根何凌云周磊罗晶何凤琴贾文君纪慧敏秦妮
Owner NANJING CORE TECH CO LTD
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