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Method for determining ranitidine hydrochloride related substances through high performance liquid chromatography

A technique of ranitidine hydrochloride and high performance liquid chromatography, which is applied in the field of determination of related substances of ranitidine hydrochloride by high performance liquid chromatography, can solve the problem of undisclosed ranitidine hydrochloride determination method, reduce risk, and fail to assess hazards To achieve the effect of facilitating quality inspection and monitoring, improving sensitivity and accuracy, and facilitating safe promotion and application

Active Publication Date: 2019-12-17
BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, when ranitidine hydrochloride is used as a drug, it is easy to produce impurities. It is known that there are 12 process impurities and degradation impurities, and its harm to the human body cannot be evaluated. Therefore, the impurities and ranitidine are effectively separated to control the amount of impurities. ,reduce risk
At present, the prior art does not disclose the assay method of 12 known impurities of ranitidine hydrochloride (i.e. the impurity A-impurity L described below), so it is necessary to provide a method for the various processes and degradation impurities of ranitidine hydrochloride Determination method

Method used

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  • Method for determining ranitidine hydrochloride related substances through high performance liquid chromatography
  • Method for determining ranitidine hydrochloride related substances through high performance liquid chromatography
  • Method for determining ranitidine hydrochloride related substances through high performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The present embodiment provides a method for the determination of related substances of ranitidine hydrochloride by high performance liquid chromatography, which is determined using the following conditions:

[0048] Chromatographic column: Octadecylsilane bonded silica gel is used as a filler; the specification of the chromatographic column is Welch-Xtimate-C18, 4.6mm×250mm, 5μm; a Yuexu peak suppressor is added in front of the column;

[0049] Mobile phase A: modified phosphate buffer solution with a volume ratio of 98:2 (dissolve 6.8ml phosphoric acid in 1900ml water, add 1ml triethylamine and 8.6ml 50% sodium hydroxide solution, add water to 2000ml; use phosphoric acid or 50 % sodium hydroxide solution to adjust the pH value to 6.70 ± 0.05) and the mixed solution of acetonitrile;

[0050] Mobile phase B: a mixture of modified phosphate buffer and acetonitrile with a volume ratio of 78:22;

[0051] Flow rate: 1.2ml / min;

[0052] Column temperature: 25°C;

[0053] ...

experiment example 1

[0064] Experimental Example 1 System Suitability Test

[0065] The preparation of need testing solution: get about 100mg of ranitidine hydrochloride, accurately weigh, put in 100ml measuring bottle, add water appropriate amount and make dissolving, dilute with water to scale, shake up, as need testing solution.

[0066] Preparation of contrast solution: accurately measure the appropriate amount of the test solution, and quantitatively dilute it with a solvent to make a solution containing 1 μg ranitidine hydrochloride in every 1ml, as a contrast solution.

[0067] Preparation of system suitability solution: ranitidine hydrochloride impurity A reference substance, impurity B reference substance, impurity C reference substance, impurity D reference substance, impurity E reference substance, impurity F reference substance, impurity G reference substance, impurity H control substance standard substance, impurity I reference substance, impurity J reference substance, impurity K ref...

experiment example 2

[0074] Experimental example 2 linearity and range test

[0075] Solvent: water

[0076] Linear stock solution: take ranitidine hydrochloride impurity A reference substance, impurity B reference substance, impurity C reference substance, impurity D reference substance, impurity E reference substance, impurity F reference substance, impurity G reference substance, impurity H reference substance, Impurity I reference substance, impurity J reference substance, impurity K reference substance, impurity L reference substance and ranitidine hydrochloride reference substance are each about 10 mg, put them in 100ml measuring bottles respectively, add a proper amount of solvent to dissolve and dilute to the mark, shake Evenly, as each stock solution, accurately measure an appropriate amount, and dilute to make a series of linear solutions.

[0077] Precisely measure 10 μl of the above-mentioned solutions, inject them into a liquid chromatograph, and record the chromatograms; the results...

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Abstract

The invention relates to the field of drug detection, in particular to a method for determining ranitidine hydrochloride related substances through high performance liquid chromatography. According tothe method disclosed by the invention, octadecylsilane chemically bonded silica is used as a filler, mobile phases comprise a mobile phase A and a mobile phase B, the mobile phase A and the mobile phase B are both a mixed solution of a modified phosphate buffer solution and acetonitrile, the pH value of the modified phosphate buffer solution is 6.70+ / -0.05, the flow velocity of the mobile phasesis 1.1-1.3ml / min, and gradient elution is adopted. By using the method disclosed by the invention, ranitidine hydrochloride related substances can be separated in a high performance liquid chromatogram. By optimizing the conditions, the sensitivity and the accuracy of the detection of each component are further improved. The method enables the quality of ranitidine hydrochloride to be better controlled, has the advantages of high analysis speed, good specificity and high reproducibility, facilitates the quality detecting and monitoring of ranitidine hydrochloride, and is beneficial to safe application and popularization of ranitidine hydrochloride.

Description

technical field [0001] The invention relates to the field of drug detection, in particular to a method for determining related substances of ranitidine hydrochloride by high performance liquid chromatography. Background technique [0002] Ranitidine hydrochloride is a histamine H2 receptor blocker, which can inhibit basic gastric acid secretion and stimulated gastric acid secretion, and can also inhibit the secretion of pepsin. Its acid-suppressing strength is 5-8 times stronger than cimetidine. In 1977, ranitidine (AH19065) was first developed by John Bradshaw's Alle n & Hanburys Co., Ltd., which is a subsidiary of GlaxoSmithKline. Ranitidine was the first in October 1981. Listed in the UK. [0003] However, when ranitidine hydrochloride is used as a drug, it is easy to produce impurities. It is known that there are 12 process impurities and degradation impurities, and its harm to the human body cannot be evaluated. Therefore, the impurities and ranitidine are effectively...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/36
CPCG01N30/02G01N30/36G01N2030/047
Inventor 宋更申李娇张婷婷
Owner BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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