Aliskiren enantiomer content detecting method

An enantiomer and detection method technology, applied in the field of content detection of aliskiren enantiomers, can solve the problem of affecting safety, affecting the quality analysis and quality control of aliskiren raw materials and preparations, and analysis and detection Obstacles and other issues to achieve the effect of ensuring safety

Inactive Publication Date: 2014-09-10
常州市亚邦医药研究所有限公司 +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This brings obstacles to the analysis and detection of aliskiren enantiomers, affects the quality analysis and quality control of aliskiren raw materials and preparations, and then affects its clinical safety

Method used

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  • Aliskiren enantiomer content detecting method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Instruments and Conditions:

[0025] High performance liquid chromatography: Shimadzu, LC-20AD pump, SPD-20A detector, CTO-20A column thermostat, LCsolution workstation;

[0026] Chromatographic column: OD-H( 250×4.6mm, 5μm);

[0027] Mobile phase: n-hexane: ethanol: diethylamine = 90:10:0.1

[0028] Detection wavelength: 230nm

[0029] Flow rate: 1.0ml / min

[0030] Column temperature: 30°C

[0031] Injection volume: 20μl

[0032] Experimental steps:

[0033] Take about 5 mg of aliskiren and aliskiren enantiomers, put them in 20ml measuring bottles respectively, add appropriate amount of mobile phase to sonicate to dissolve, dilute to the mark, shake well, and use it as a system adaptability solution. Precisely measure 20 μl of the system adaptability solution, carry out high-performance liquid chromatography analysis according to the above conditions, record the chromatogram, and see the results in figure 1 .

[0034] figure 1 The chromatographic peak with a...

Embodiment 2

[0036] Instruments and Conditions:

[0037] High performance liquid chromatography: Shimadzu, LC-20AD pump, SPD-20A detector, CTO-20A column thermostat, LCsolution workstation;

[0038] Chromatographic column: OD-H( 250×4.6mm, 5μm);

[0039] Mobile phase: n-hexane: ethanol: diethylamine = 92:8:0.1

[0040] Detection wavelength: 230nm

[0041] Flow rate: 1.0ml / min

[0042] Column temperature: 30°C

[0043] Injection volume: 20μl

[0044] Experimental steps:

[0045] Take about 5 mg of aliskiren and aliskiren enantiomers, put them in 20ml measuring bottles respectively, add appropriate amount of mobile phase to sonicate to dissolve, dilute to the mark, shake well, and use it as a system adaptability solution. Precisely measure 20 μl of the system adaptability solution, carry out high-performance liquid chromatography analysis according to the above conditions, record the chromatogram, and see the results in figure 2 .

[0046] figure 2 The chromatographic peak with ...

Embodiment 3

[0048] Instruments and Conditions:

[0049] High performance liquid chromatography: Shimadzu, LC-20AD pump, SPD-20A detector, CTO-20A column thermostat, LCsolution workstation;

[0050] Chromatographic column: OD-H( 250×4.6mm, 5μm);

[0051] Mobile phase: n-hexane: ethanol: diethylamine = 94:6:0.1

[0052] Detection wavelength: 230nm

[0053] Flow rate: 1.0ml / min

[0054] Column temperature: 30°C

[0055] Injection volume: 20μl

[0056] Experimental steps:

[0057] Take about 5 mg of aliskiren and aliskiren enantiomers, put them in 20ml measuring bottles respectively, add appropriate amount of mobile phase to sonicate to dissolve, dilute to the mark, shake well, and use it as a system adaptability solution. Precisely measure 20 μl of the system adaptability solution, carry out high-performance liquid chromatography analysis according to the above conditions, record the chromatogram, and see the results in image 3 .

[0058] image 3The chromatographic peak with a r...

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Abstract

The invention discloses an aliskiren enantiomer content detecting method which is a high performance liquid chromatography. The aliskiren enantiomer content detecting method comprises the steps that the surface of silica gel is coated with a normal-phase chromatographic column with a cellulose-three[3,5-xylyl carbamate] chiral stationary phase as padding, the mixed solvent of the normal hexane, the ethyl alcohol and the organic amine polarity modifier as the mobile phase, the volume proportion of the normal hexane, the ethyl alcohol and the organic amine polarity modifier is 90-94:6-10:0-0.5, detection is carried out through an ultraviolet detector, the flow velocity is 0.6-1.0ml / min, and the temperature of the chromatographic column ranges from 25 DEG C to 40 DEG C. According to the method, the aliskiren and the enantiomer corresponding to the aliskiren can be well separated, and therefore the content of the enantiomer of the aliskiren can be accurately measured, and the method can be used for carrying out quality control on the studying and producing process of the raw aliskiren medicine and the preparations of the raw aliskiren medicine.

Description

technical field [0001] The invention relates to a method for detecting the content of an aliskiren enantiomer, belonging to the field of drug analysis. Background technique [0002] Aliskiren (Aliskiren) is a new non-peptide oral low molecular weight non-peptide renin inhibitor pioneered by Novartis Pharmaceuticals. It has a good antihypertensive effect through clinical research (better antihypertensive effect on renin-type hypertension), It has become a new antihypertensive drug with few side effects and high safety. In March 2007, it was approved for marketing by the US FDA, and the active ingredient exists in the form of hemifumarate. In June 2010, it was approved by the SFDA of China for the treatment of hypertension alone or in combination with other antihypertensive drugs in China. [0003] Aliskiren is a new antihypertensive drug developed by molecular simulation of the active site of renin based on X-ray crystallography. It has a strong, stable and long-lasting ant...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 陈再新李小兵王勇军朱峰黄静蒋晓勤
Owner 常州市亚邦医药研究所有限公司
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