Detection method of related substances in compound ammonium barbiturate injection

A compound aminolimbarbital and detection method technology, which is applied to measurement devices, instruments, scientific instruments and other directions, can solve problems such as difficulties, establishment of substance detection methods, and chromatographic column consumption, and achieves a wide range of applications and drug safety assurance. Effect

Active Publication Date: 2016-04-13
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there are also reports in the literature on the method of simultaneously measuring the content of the three components, but ion pairing reagents are required and the pH value is too high, which will easily lead to rapid consumption of the chromatographic column, and the preparation is a compound preparation of three components, and the detection of related substances It is difficult to establish the method
At present, there is no literature report on the detection method of related substances in compound ammonium barbiturate injection

Method used

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  • Detection method of related substances in compound ammonium barbiturate injection
  • Detection method of related substances in compound ammonium barbiturate injection
  • Detection method of related substances in compound ammonium barbiturate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Embodiment 1 Detection method of the present invention

[0065] Instruments and conditions: Agilent1200 liquid chromatograph, DAD detector, chromatographic column: AgilentTC-C18 (250mm*4.6mm, 5um); detection wavelength: 220nm; column temperature: 30°C; buffered with 0.02mol / L potassium dihydrogen phosphate solution (pH adjusted to 5.5) - acetonitrile = 85:15 as mobile phase A, acetonitrile as mobile phase B, perform linear gradient elution in the following table.

[0066] time / minute

Mobile phase A / %

Acetonitrile / %

0

100

0

30

100

0

50

50

50

55

50

50

56

100

0

65

100

0

[0067] main peak positioning

[0068]Take appropriate amount of reference substances of aminopyrine, antipyrine and barbiturate respectively, add mobile phase A to prepare solutions with concentrations of 0.05mg / ml, 0.02mg / ml, and 0.009mg / ml. Take another 1ml of compound ammonium barbiturate in...

Embodiment 2

[0074] Embodiment 2 detection method of the present invention

[0075] Instruments and conditions: Agilent1200 liquid chromatograph, DAD detector, chromatographic column: AgilentTC-C18 (250mm*4.6mm, 5um); detection wavelength: 220nm; column temperature: 30°C; buffered with 0.02mol / L potassium dihydrogen phosphate solution (pH adjusted to 6.0)-acetonitrile=85:15 as mobile phase A, acetonitrile as mobile phase B, and perform linear gradient elution in the following table.

[0076] time / minute

[0077] Take 1ml of compound ammonium barbiturate injection and put it in a 100ml measuring bottle, after diluting and constant volume with mobile phase A, detect according to the above method, the HPLC spectrum is shown in image 3 .

Embodiment 3

[0078] Embodiment 3 Determination of Related Substances of Compound Ammonium Barbital Injection

[0079] Instruments and conditions: Agilent1200 liquid chromatograph, DAD detector, chromatographic column: AgilentTC-C18 (250mm*4.6mm, 5um); detection wavelength: 220nm; column temperature: 30°C; buffered with 0.02mol / L potassium dihydrogen phosphate solution (adjusted to pH 5.5)-acetonitrile=83:17 as mobile phase A, and acetonitrile as mobile phase B, perform linear gradient elution in the following table.

[0080] time / minute

[0081] Experimental procedure: Measure 1ml of the long-term 36-month sample of compound ammonium barbiturate injection preparation and place it in a 100ml measuring bottle, add mobile phase A to constant volume and shake up, measure according to the law, see HPLC spectrum Figure 4 .

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Abstract

The invention discloses a detection method for relative substances in a compound aminophenazone and barbital injection. The method utilizes a high performance liquid chromatography to determine. The detection method disclosed by the invention can be used for completely separating the peaks of effective components and impurities of the compound aminophenazone and barbital injection at the same time. The invention provides an effective relative substance detection method. Meanwhile, the method can be used for effectively detecting impurities generated in products which are stored for long time or are degraded, has a wide applicable range and provides guarantees to medicine safety of the injection.

Description

technical field [0001] The invention relates to a detection method for related substances in compound ammonium barbiturate injection. Background technique [0002] Compound aminopyrine-barbital injection is a compound preparation composed of aminopyrine 100mg, antipyrine 40mg, and barbiturate 18mg. Aminopyrine and antipyrine belong to pyrazolone antipyretic and analgesic drugs, which can inhibit the synthesis and release of hypothalamic prostaglandin, restore the normal reactivity of sensory neurons in the temperature regulation center and play an antipyretic effect; Inhibit the synthesis of prostaglandins and other analgesic effect. Aminopyrine can inhibit the synthesis and release of prostaglandins in local tissues of inflammation, stabilize the lysosome membrane, and affect the phagocytosis of phagocytes to play an anti-inflammatory effect. Combined use of barbiturates can enhance the analgesic effect. [0003] In 2003, the compound ammonium barbiturate injection was l...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88
Inventor 高国玉赵瀚晶王静周莉娅梁隆王利春沈鑫程志鹏
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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