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Method for controlling mass of related substance of pramipexole dihydrochloride tablet

A technology of pramipexole hydrochloride and pramipexole tablets, which is applied in the field of drug testing and can solve problems such as interference

Active Publication Date: 2018-05-29
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] After research, it was found that the excipient cornstarch used in the existing tablets interfered with the detection method of related substances in the preparation, and the specific performance was that a series of interference peaks would be generated in the detection at 262nm, 326nm, and 240nm wavelengths

Method used

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  • Method for controlling mass of related substance of pramipexole dihydrochloride tablet
  • Method for controlling mass of related substance of pramipexole dihydrochloride tablet
  • Method for controlling mass of related substance of pramipexole dihydrochloride tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0183] Chromatographic conditions:

[0184] Use octadecylsilane bonded silica gel as filler (Shiseido CAPCELL PAK C18MGⅡ150mm × 4.6mm, 5μm);

[0185] Mobile phase A is ammonium formate buffer (pH5.0), and mobile phase B is methanol;

[0186] The flow rate is 1.0ml / min;

[0187] Column temperature 35°C;

[0188] Using an array diode detector for detection, the detection wavelengths are 240nm, 262nm and 326nm;

[0189] The elution gradient is:

[0190] time (min)

Mobile phase A (V / V%)

Mobile phase B (V / V%)

0

99

1

5

99

1

38

44

56

40

99

1

50

99

1

[0191] The separation degree of each component peak in the reference solution should meet the requirements; another about 10 mg of pramipexole hydrochloride crude drug was placed in a 50 ml measuring bottle, dissolved with mobile phase and diluted to the scale, shaken, measured 10 ml and transferred to a non-glass (Quartz or transparent ...

Embodiment 2

[0204] Chromatographic conditions:

[0205] Use octadecylsilane bonded silica gel as filler (Shiseido CAPCELL PAK C18MGⅡ150mm × 4.6mm, 5μm);

[0206] Mobile phase A is ammonium formate buffer (pH4.8), and mobile phase B is methanol;

[0207] The flow rate is 1.1ml / min;

[0208] Column temperature 30°C;

[0209] Using an array diode detector for detection, the detection wavelengths are 240nm, 262nm and 326nm;

[0210] The elution gradient is:

[0211] time (min)

Mobile phase A (V / V%)

Mobile phase B (V / V%)

0

99

1

5

99

1

38

44

56

40

99

1

50

99

1

[0212] The separation degree of each component peak in the reference solution should meet the requirements; another about 10 mg of pramipexole hydrochloride crude drug was placed in a 50 ml measuring bottle, dissolved with mobile phase and diluted to the scale, shaken, measured 10 ml and transferred to a non-glass (Quartz or transparent ...

Embodiment 3

[0225] Chromatographic conditions:

[0226] Use octadecylsilane bonded silica gel as filler (Shiseido CAPCELL PAK C18MGⅡ150mm × 4.6mm, 5μm);

[0227] Mobile phase A is ammonium formate buffer (pH5.0), and mobile phase B is methanol;

[0228] The flow rate is 0.9ml / min;

[0229] Column temperature 30°C;

[0230] Using an array diode detector for detection, the detection wavelengths are 240nm, 262nm and 326nm;

[0231] The elution gradient is:

[0232] time (min)

Mobile phase A (V / V%)

Mobile phase B (V / V%)

0

99

1

5

99

1

38

44

56

40

99

1

50

99

1

[0233] The separation degree of each component peak in the reference solution should meet the requirements; another about 10 mg of pramipexole hydrochloride crude drug was placed in a 50 ml measuring bottle, dissolved with mobile phase and diluted to the scale, shaken, measured 10 ml and transferred to a non-glass (Quartz or transparent ...

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Abstract

The invention discloses a method for controlling the mass of related substances of pramipexole dihydrochloride tablets. The method comprises the following steps: 1) preparing a test sample solution; 2) preparing a blank auxiliary material solution; 3) preparing a reference product standby solution; 4) preparing a reference product solution; 5) preparing a light degradation positioning solution; 6)performing detection.

Description

technical field [0001] The invention belongs to the field of drug testing, and in particular relates to a method for controlling the quality of related substances in pramipexole hydrochloride tablets. Background technique [0002] Elderly patients with Parkinson's disease generally have difficulty swallowing medicines, so tablets that need to be swallowed whole will be inconvenient for elderly patients in the process of taking medicine. Compared with ordinary tablets, orally disintegrating tablets do not require water or chewing. When the drug is placed on the tongue, it will quickly disintegrate into fine particles when it encounters saliva, and enter the stomach with swallowing saliva. The drug has a fast dissolution rate, so it has the characteristics of fast onset and high bioavailability. [0003] Pramipexole hydrochloride is a dopamine receptor agonist that is pharmacologically a full agonist and has receptor selectivity for the dopamine D2 family of dopamine receptor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 韩冬孙玉刚郭嘉林孔凯刘登科董凯
Owner TIANJIN CHASE SUN PHARM CO LTD
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