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Method for measuring ambrisentan content through high performance liquid chromatography

A high-performance liquid chromatography and ambrisentan technology, which is applied in the field of high-performance liquid chromatography to determine the content of ambrisentan, achieves strict and effective control, and meets the needs of research and development and production.

Inactive Publication Date: 2016-11-09
JIANGSU SINOBIOPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] There is no literature report on the content analysis method of the raw material drug, and the dosage form of ambrisentan currently on the market is a tablet with a specification of 5 mg

Method used

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  • Method for measuring ambrisentan content through high performance liquid chromatography
  • Method for measuring ambrisentan content through high performance liquid chromatography
  • Method for measuring ambrisentan content through high performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] The amount of phosphate added in the phosphate buffer solution of phase A is 10mmol / L; the pH value of the phosphate is 2, and the mixing volume ratio of phase B and phase A is 40:60.

[0027] The specific operation steps of measuring ambrisentan content are:

[0028] (1) Take 20mg ambrisentan tablet, weigh it accurately, put it in a measuring bottle, add diluent to dissolve and dilute to a solution containing 0.05mg ambrisentan per 1mL, as the test solution, the diluent is Mixture of water and acetonitrile, the mixing volume ratio of water and acetonitrile is 25:75;

[0029] (2) Precisely measure 20 μl of the test solution, inject it into the liquid chromatograph, and record the chromatogram;

[0030] (3) Take 20mg ambrisentan tablet, weigh it accurately, place it in a measuring bottle, add diluent to dissolve and dilute to a solution containing 0.05mg ambrisentan per 1mL, as the reference solution, the diluent is water Mixed liquid with acetonitrile, the mixing volu...

Embodiment 2

[0034] The amount of phosphate added in the phosphate buffer solution of phase A is 60mmol / L; the pH value of phosphate is 4, and the mixing volume ratio of phase B and phase A is 60:40.

[0035] The specific operation steps of measuring ambrisentan content are:

[0036] (1) Take 150mg ambrisentan tablet, weigh it precisely, place it in a measuring bottle, add diluent to dissolve and dilute to a solution containing 0.05mg ambrisentan per 1mL, as the test solution, the diluent is Mixture of water and acetonitrile, the mixing volume ratio of water and acetonitrile is 25:75;

[0037] (2) Precisely measure 20 μl of the test solution, inject it into the liquid chromatograph, and record the chromatogram;

[0038] (3) Take 150mg ambrisentan tablet, weigh it precisely, place it in a measuring bottle, add diluent to dissolve and dilute to a solution containing 0.05mg ambrisentan per 1mL, as the reference solution, the diluent is water Mixed liquid with acetonitrile, the mixing volume...

Embodiment 3

[0042] The amount of phosphate added in the phosphate buffer solution of phase A is 35mmol / L; the pH value of phosphate is 3, and the mixing volume ratio of phase B and phase A is 45:55.

[0043] The specific operation steps of measuring ambrisentan content are:

[0044] (1) Take 85mg ambrisentan tablet, weigh it precisely, place it in a measuring bottle, add diluent to dissolve and dilute to a solution containing 0.05mg ambrisentan per 1mL, as the test solution, the diluent is Mixture of water and acetonitrile, the mixing volume ratio of water and acetonitrile is 25:75;

[0045] (2) Precisely measure 20 μl of the test solution, inject it into the liquid chromatograph, and record the chromatogram;

[0046] (3) Take 85mg ambrisentan tablet, weigh it accurately, place it in a measuring bottle, add diluent to dissolve and dilute to a solution containing 0.05mg ambrisentan per 1mL, as the reference solution, and the diluent is water Mixed liquid with acetonitrile, the mixing vol...

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Abstract

The invention discloses a method for measuring the ambrisentan content through a high performance liquid chromatography. The chromatographic conditions are as follows: the octadecylsilane bonded silica gel is selected as a filler, the column length is 250 mm, the detection wavelength is 220 nm, the column temperature is 35 DEG C, and the flow velocity is 1.0 ml / min; elution is conducted according to gradient by adoption of a reversed-phase high performance liquid chromatography, the mobile phases are a phosphate buffered solution and a polar organic solvent, the phosphate buffered solution is the A phase, the polar organic solvent is the B phase, and an organic solvent of the B phase in the mobile phases is acetonitrile. According to the method, the reversed-phase high performance liquid chromatography is adopted, a test solution and a contrast solution are prepared, 20 [mu]l of the test solution and the contrast solution are measured respectively to be injected into a chromatographic instrument, a chromatogram is recorded, the peak area is calculated according to an external standard method, and drying calculation is conducted so as to realize measurement of the ambrisentan content. The method fills up the vacancy that no ambrisentan content measurement and analysis method exists in the prior art, can meet the requirements on research, development and production, and can effectively conduct relatively strict and effective control on the ambrisentan content.

Description

technical field [0001] The present invention relates to the quality control method of the national 3.1 new drug ambrisentan crude drug, with [0002] The invention relates to a method for determining the content of ambrisentan by high performance liquid chromatography. Background technique [0003] Endothelin-1 (ET-1) is a potent autocrine and paracrine peptide. Both receptor subtypes (ETA and ETB) co-regulate the actions of ET-1 in vascular smooth muscle and endothelial cells. The main effects of ETA are vasoconstriction and cell proliferation, while the main effects of ETB are vasodilation, inhibition of proliferation, and removal of ET-1. [0004] In patients with pulmonary hypertension, plasma ET-1 concentrations are 10-fold higher and correlate with increased mean right atrial pressure and disease severity. The concentrations of ET-1 and ET-1mRNA in pulmonary tissue of patients with pulmonary hypertension increased 9-fold, mainly concentrated in pulmonary artery endo...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 黄乐群周磊
Owner JIANGSU SINOBIOPHARMA
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