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Method for separating imidafenacin and related substances thereof by using high performance liquid chromatography

A technology of new midanna and related substances, applied in the field of analytical chemistry, can solve problems such as incomplete removal of intermediates, affecting the purity and quality of drugs, and achieve quality controllable results

Active Publication Date: 2015-05-13
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the production process of the new process of producing midana, some important intermediates may be incompletely removed, thus affecting the purity and quality of the drug

Method used

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  • Method for separating imidafenacin and related substances thereof by using high performance liquid chromatography
  • Method for separating imidafenacin and related substances thereof by using high performance liquid chromatography
  • Method for separating imidafenacin and related substances thereof by using high performance liquid chromatography

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Instruments and Conditions

[0041] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0042] Column: C 18 (ES, 250×4.6mm, 5μm)

[0043] Mobile phase A: 0.02mol / L dipotassium hydrogen phosphate (pH 7.0)

[0044] B: Acetonitrile

[0045] Elute with a concentration gradient:

[0046] T(min) 0 25 40 50 60 75 76 85 B% 30 30 60 60 70 70 30 30

[0047] Flow rate: 1.0mL / min

[0048] Detection wavelength: 210nm

[0049] Column temperature: 30°C

[0050] Injection volume: 10μL

[0051] Experimental steps:

[0052] Take an appropriate amount of midanacin and its related substances, dissolve the samples in acetonitrile respectively, and prepare a sample solution containing about 0.5 mg / mL of midanacin and its related substances; another appropriate amount of acetonitrile is used as a blank solvent. Perform HPLC analysis according to the above conditions, and record the chromatograms. se...

Embodiment 2

[0054] Instruments and Conditions

[0055] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0056] Column: C 18 (ES, 250×4.6mm, 5μm)

[0057] Mobile phase A: 0.02mol / L dipotassium hydrogen phosphate (pH 7.0)

[0058] B: Acetonitrile

[0059] Elute with a concentration gradient:

[0060] T(min) 0 5 55 65 75 B% 30 30 75 30 30

[0061] Flow rate: 1.0mL / min

[0062]Detection wavelength: 210nm

[0063] Column temperature: 30°C

[0064] Injection volume: 10μL

[0065] Experimental steps:

[0066] Take an appropriate amount of midanacin and its related substances, dissolve the samples in acetonitrile respectively, and prepare a sample solution containing about 0.5 mg / mL of midanacin and its related substances; another appropriate amount of acetonitrile is used as a blank solvent. Perform HPLC analysis according to the above conditions, and record the chromatograms. see attached results Figur...

Embodiment 3

[0068] Instruments and Conditions

[0069] Chromatographic column: Phenyl (Ultimate, 250×4.6mm, 5μm)

[0070] Mobile phase A: 0.02mol / L dipotassium hydrogen phosphate (pH 7.0)

[0071] B: Acetonitrile

[0072] Elute with a concentration gradient:

[0073] T (min) 0 5 55 56 65 B（%） 30 30 75 30 30

[0074] Detection wavelength: 210nm

[0075] Column temperature: 30°C

[0076] Injection volume: 10μL

[0077] Experimental steps:

[0078] Take an appropriate amount of midanacin and its related substances, dissolve the samples in acetonitrile respectively, and prepare a sample solution containing about 0.5 mg / mL of midanacin and its related substances; another appropriate amount of acetonitrile is used as a blank solvent. Perform HPLC analysis according to the above conditions, and record the chromatograms. see attached results Figure 6~7 , Image 6 The chromatographic peak with a retention time of 20.805min is midanacine, and the remaining chro...

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Abstract

The invention belongs to the field of analytical chemistry and discloses a method for separating and determining imidafenacin and related substances thereof by using liquid chromatography. The method can be used for quantitatively determining the contents of imidafenacin and related substances thereof by using phenyl silane bonded silica gel as a chromatographic column of fillers and a certain proportion of buffer salt solutions-organic phases as mobile phases, thus effectively controlling the quality of imidafenacin. The method has strong specificity and high precision and is simple and convenient to operate.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a liquid chromatography separation and determination method for midanacin and its related substances. Background technique [0002] Midanacin is a new type of high-efficiency anticholinergic drug with a diphenylbutyramide structure, which is used for the treatment of overactive bladder. Mida's new English name is imidafenacin, and its chemical name is 4-(4-methyl-1H-imidazol-1-yl)-2,2-diphenylbutyramide (4-(2-methyl-1H-imidazol- 1-yl)-2,2-dipheybutanamide), the molecular formula is C 20 h 21 N 3 O, the new structural formula of Midana is: [0003] [0004] There are different subtypes of muscarinic receptors (M receptors) distributed in the human body, which play different physiological roles in different parts. M1, M2 and M3 receptors are mainly distributed in bladder tissue. Overactive bladder (Overactive Bladder, OAB) is a syndrome characterized by symp...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 赵路路王宇杰马苏峰
Owner BEIJING VENTUREPHARM BIOTECH
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