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A method for the determination of related substances of ranitidine hydrochloride by high performance liquid chromatography

A technology of ranitidine hydrochloride and high performance liquid chromatography, which is applied in the field of high performance liquid chromatography for the determination of ranitidine hydrochloride related substances, can solve the problem of inability to assess hazards, reduce risks, and unpublished ranitidine hydrochloride determination methods. and other problems, to achieve the effect of facilitating quality inspection and monitoring, improving sensitivity and accuracy, and facilitating safe promotion and application

Active Publication Date: 2022-04-05
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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  • A method for the determination of related substances of ranitidine hydrochloride by high performance liquid chromatography
  • A method for the determination of related substances of ranitidine hydrochloride by high performance liquid chromatography
  • A method for the determination of related substances of ranitidine hydrochloride by high performance liquid chromatography

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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 related substances of ranitidine hydrochloride by high performance liquid chromatography. The method of the present invention adopts octadecylsilane bonded silica gel as a packing agent; Mobile phase comprises mobile phase A and mobile phase B, and described mobile phase A and mobile phase B are modified phosphate buffer saline and acetonitrile For the mixed solution, the pH value of the modified phosphate buffer solution is 6.70±0.05; the flow rate of the mobile phase is 1.1-1.3ml / min; gradient elution is adopted. The method of the invention can separate the related substances of ranitidine hydrochloride in the high-performance liquid chromatogram; and through optimizing the conditions, the sensitivity and accuracy of detecting each component are further improved. The method can better control the quality of ranitidine hydrochloride, and at the same time, the analysis speed is fast, the specificity is good, and the reproducibility is high. Security promotion and application.

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 Patents(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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