Method for detecting related substances in irbesartan hydrochlorothiazide tablets by adopting high performance liquid chromatography

A technology of high performance liquid chromatography and chlorothiazide tablets, which is applied in the field of high performance liquid chromatography to detect related substances in irbesartan and hydrochlorothiazide tablets, can solve solvent peak interference, hydrochlorothiazide impurity chlorothiazide cannot be completely separated, and peak shape is poor And other issues

Active Publication Date: 2017-05-24
NORTHEAST PHARMA GRP SHENYANG SHIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, only the method for impurity detection of irbesartan and hydrochlorothiazide tablets is recorded on the USP forum, but the retention time of the impurity sulfonamide in this method is too early, and there is interfere

Method used

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  • Method for detecting related substances in irbesartan hydrochlorothiazide tablets by adopting high performance liquid chromatography
  • Method for detecting related substances in irbesartan hydrochlorothiazide tablets by adopting high performance liquid chromatography
  • Method for detecting related substances in irbesartan hydrochlorothiazide tablets by adopting high performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0036] Experimental example 1:

[0037] According to the method for determining irbesartan hydrochlorothiazide tablets of the present invention, the accelerated sample samples of self-made irbesartan hydrochlorothiazide tablets with the batch number of 20131104 year were measured, and the content of each impurity in the related substance items was checked.

[0038] Take 10 pieces of the lot number sample and grind finely, weigh 150.23mg, put it in a 100ml measuring flask, add 30ml solvent, ultrasound for 10 minutes, let cool, dilute with solvent to the mark, shake well, and filter; accurately measure the continuous filtrate 7.5ml , Put in a 50ml measuring flask, dilute to the mark with solvent, and shake well to get.

[0039] Reference substance: Reference substance solution (a): Accurately weigh 15.14mg of irbesartan reference substance, accurately weigh it, and place it in a 25ml measuring flask. Add 5ml solvent to ultrasonic for 2 minutes to dissolve, dilute to the mark with solve...

Example Embodiment

[0053] According to the calculation formula, sulfanamide: 0.50%, irbesartan impurity A: 0.08%, single impurities: 0.05%, total impurities 0.65%. Experimental example two

[0054] 1.1 Selection of detection wavelength

[0055] Accurately weigh appropriate amount of irbesartan and irbesartan A reference substance and dissolve it in the above solvent and dilute to volume to prepare a mixed reference solution of about 20μg / ml; accurately weigh out appropriate amount of hydrochlorothiazide reference substance and dissolve it in a solvent and dilute to volume. Prepare a mixed reference solution of 20μg / ml solution, use the solvent as a blank, scan in the wavelength range of 200-400nm according to ultraviolet spectrophotometry, and record the ultraviolet absorption spectrum.

[0056] By the attachment figure 1 Irbesartan figure 2 Hydrochlorothiazide shows that in the 200-300nm wavelength range, hydrochlorothiazide is at 220nm (see figure 2 Reference numeral 1), 270nm and 312nm have maxi...

Example Embodiment

[0071] Example 2

[0072] Methodology establishment

[0073] 2.1 Specificity

[0074] The preparation of the specific solution is prepared according to the preparation method of the reference substance (2) in this patent, and 20μl each of the above linear solution is accurately measured, injected into the liquid chromatograph, and the chromatogram is recorded, see image 3 . Attached image 3 The one marked 2 is irbesartan, attached image 3 The one marked 1 in the figure is Irbesartan A, the one marked 3 in the figure is sulfa, and the one marked 4 in the figure is hydrochlorothiazide.

[0075] Table 3 Specific chromatographic separation table

[0076]

[0077] The test results show that the solvent peaks early and does not interfere with the detection of related substances; see the attachment in the mixed control solution of impurities and the system suitability test solution image 3 Available, sulfa (see image 3 Reference number 3) and hydrochlorothiazide (see image 3 Reference n...

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Abstract

The invention belongs to the field of pharmaceutical analysis and particularly relates to a method for detecting related substances in irbesartan hydrochlorothiazide tablets by adopting high performance liquid chromatography. The method comprises the steps that 1, chromatographic conditions are firstly determined through a chromatographic column, column temperature, detection wave length and a mobile phase; 2, a test sample solution and a reference substance solution are prepared; 3, a determination method is adopted to perform precision determination of the test sample solution and the reference substance solution respectively, the solutions are injected into a liquid chromatograph, a chromatogram is recorded, and calculation is performed according to a self-contrasting method and a correction factor self-contrasting method; a main peak of the test sample solution and a main peak of the reference substance solution are consistent in retention time, and accordingly the method is achieved.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for detecting related substances in irbesartan hydrochlorothiazide tablets by using high performance liquid chromatography. Background technique [0002] Irbesartan Hydrochlorothiazide Tablets are developed by Sanofi Company, and the trade name is COAPROVEL. It was listed in the UK in 1998 and successfully listed in China in 2004. Since the antihypertensive mechanisms of the two drugs are different, the combination of the compound preparation will produce a synergistic effect on reducing blood pressure and enhance the antihypertensive effect, and can complement each other's deficiencies, reduce or offset the adverse reactions that may occur when the single drug is used for a long time, thereby increasing the patient's medication. compliance. According to literature and United States Pharmacopoeia standards, the known impurity in hydrochlorothiazide raw m...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 周鹏关旭久张旭胥杨李静阎日红糜桑桑
Owner NORTHEAST PHARMA GRP SHENYANG SHIDE PHARMA
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