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A kind of high-efficiency liquid phase detection method of rotafoxine tablets

A detection method and high-performance liquid phase technology, applied in the field of analytical chemistry, can solve the problems of large damage to the chromatographic column, contamination of the chromatographic column, high analysis cost, etc., and achieve the effects of avoiding component interference, short analysis time and easy operation

Active Publication Date: 2020-11-20
ZHAOKE PHARMA HEFEI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the original method was used to detect the dissolution profile of rotafoxin enteric-coated tablets, after multiple injections, the chromatographic column was polluted, the column efficiency decreased, and interference appeared before and after the main peak of rotafoxin. not big
The original method is more harmful to the chromatographic column, and the analysis cost is high

Method used

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  • A kind of high-efficiency liquid phase detection method of rotafoxine tablets
  • A kind of high-efficiency liquid phase detection method of rotafoxine tablets
  • A kind of high-efficiency liquid phase detection method of rotafoxine tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Solution preparation: take this product, according to the dissolution method (Chinese Pharmacopoeia 2015 edition four general rules 0931 second method), with hydrochloric acid solution (9→1000): hydrochloric acid solution is 0.1M hydrochloric acid solution, 9→1000: take 9ml concentrated hydrochloric acid Dilute to 1000ml to obtain 0.1M hydrochloric acid solution. This hydrochloric acid solution 500ml is stripping medium, and rotating speed is 75 revolutions per minute, operates according to law, after 120 minutes, take out for testing piece immediately, each piece all must not have crack, disintegration or softening phenomenon. Immediately put this product into 500ml pH6.8 phosphate buffer solution preheated to 37°C, the rotation speed is 40 rpm, operate according to the law, after 80 minutes, take out a proper amount of the solution and filter it as the test solution.

[0041] Preparation of reference solution

[0042] name purity batch number source ...

Embodiment 2

[0058] Solution preparation: take this product, according to the dissolution method (Chinese Pharmacopoeia 2015 edition four general rules 0931 second method), with hydrochloric acid solution (9→1000): hydrochloric acid solution is 0.1M hydrochloric acid solution, 9→1000: take 9ml concentrated hydrochloric acid Dilute to 1000ml to obtain 0.1M hydrochloric acid solution. This hydrochloric acid solution 500ml is stripping medium, and rotating speed is 75 revolutions per minute, operates according to law, after 120 minutes, take out for testing piece immediately, each piece all must not have crack, disintegration or softening phenomenon. Immediately put this product into 500ml pH6.8 phosphate buffer solution preheated to 37°C, the speed is 60 revolutions per minute, operate according to the law, after 100 minutes, take out a proper amount of the solution and filter it as the test solution.

[0059] Preparation of reference solution

[0060] name purity batch number...

Embodiment 3

[0076] Solution preparation: take this product, according to the dissolution method (Chinese Pharmacopoeia 2015 edition four general rules 0931 second method), with hydrochloric acid solution (9→1000): hydrochloric acid solution is 0.1M hydrochloric acid solution, 9→1000: take 9ml concentrated hydrochloric acid Dilute to 1000ml to obtain 0.1M hydrochloric acid solution. This hydrochloric acid solution 500ml is stripping medium, and rotating speed is 75 revolutions per minute, operates according to law, after 120 minutes, take out for testing piece immediately, each piece all must not have crack, disintegration or softening phenomenon. Immediately put this product into 500ml pH6.8 phosphate buffer solution preheated to 37°C, the rotation speed is 50 rpm, operate according to the law, after 90 minutes, take out a proper amount of the solution and filter it as the test solution.

[0077] Preparation of reference solution

[0078] name purity batch number source ...

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Abstract

The invention discloses a high-performance liquid chromatography method for rostafuroxin tablets. The method includes steps: (1) preparing reference solution, to be more specific, using acetonitrile for dissolving a standard substance of rostafuroxin in purity of 98%, diluting with phosphate buffer solution in pH of 6.8 to obtain liquid in concentration of 0.5-1.5 microgram / ml; (2) preparing testsolution, to be more specific, dissolving the rostafuroxin tablets into phosphate buffer solution in pH of 6.8, stirring at a constant temperature, and filtering to obtain the test solution; (3) subjecting the test solution and the reference solution to high-performance liquid chromatography under conditions that chromatographic columns with filler of octadecyl silane bonded silica gel are adopted, acetonitrile serves as a flowing phase A, acid aqueous solution serves as a flowing phase B, a flow velocity is 0.5-1.0ml / min, a detection wavelength is 205-230nm, and a column temperature is 20-40DEG C. The method is high in number of theoretical plates, and influences on detection result accuracy due to component interference are effectively avoided. In addition, the method has advantages ofaccuracy and reliability in detection result, short analysis time, low cost, simplicity and convenience in operation and the like.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a high-efficiency liquid phase detection method for rotafoxine tablets. Background technique [0002] Rostafuroxin, Rostafuroxin is a novel ouabain antagonist—it can reduce blood pressure in patients with ouabain-induced salt-dependent hypertension by antagonizing the effect of ouabain on renal Na+-K+-ATPase. The drug specifically acts on the gene expression protein of patients with specific genes. It can effectively lower the blood pressure of patients, and the effect of lowering blood pressure is more significant than that of ordinary antihypertensive drugs. [0003] Rotafuxin is the research object of this experiment, and it is the main drug of Rotafuxin enteric-coated tablets. The detection of the dissolution rate of Rotafuxin enteric-coated tablets can guide the adjustment of our preparation process. [0004] After reviewing relevant literature and patents a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 张莹莹吴涛李小羿戴向荣殷雷凌娟
Owner ZHAOKE PHARMA HEFEI
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