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Ranitidine hydrochloride detection method and application thereof

A technology of ranitidine hydrochloride and its detection method, which is applied in the field of liquid chromatography, can solve the problems of severe tailing, poor peak shape of impurities, inaccurate quantification, etc., and achieve the control of improved impurity content, reduction of tailing factor, and testing high precision effect

Pending Publication Date: 2020-06-12
FOSHAN SOIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, during the sample detection process using the above method, it was found that the separation between the various impurities was not very good, and each impurity could not be accurately separated, and some impurities had poor peak shapes and severe tailing (the tailing factor was 2.1), which could not be accurately quantified. , so that the same batch of samples is tested multiple times, and the results of related substances cannot be reproduced, so that it cannot accurately reflect the situation of related substances in the product

Method used

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  • Ranitidine hydrochloride detection method and application thereof
  • Ranitidine hydrochloride detection method and application thereof
  • Ranitidine hydrochloride detection method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0056] The present embodiment provides a kind of detection method of ranitidine hydrochloride, and its steps are as follows:

[0057] (1) Ranitidine tablet is mixed with mobile phase, obtains the solution to be tested;

[0058] Specifically, the ranitidine produced by a certain company is taken as the test object; it is ground into a fine powder, and an appropriate amount of fine powder (approximately equivalent to 25 mg of ranitidine) under the content determination item is accurately weighed, and placed in a 25mL volumetric flask In, add the first mobile phase to dissolve and dilute to the mark, take the filtrate as need testing solution. Accurately measure 1ml, put it in a 100ml measuring bottle, dilute to the mark with the first mobile phase, shake well, then precisely measure 5ml of the solution, put it in a 25ml measuring bottle, dilute to the mark with the first mobile phase, shake well, as Control solution.

[0059] (2) The test solution is injected into a liquid chr...

Embodiment 2

[0077] Embodiment 2 quantitative limit experiment

[0078] The specific test method is as follows:

[0079] Take impurity A solution with a concentration of 500 μg / mL and other impurity solutions with a concentration of 200 μg / mL, continuously dilute with diluent and inject samples, record the chromatogram until the peak signal-to-noise ratio (S / N) ≈ 10, calculate the components Limit of quantitation and limit of quantitation concentration.

[0080] Prepare 6 quantitation limit solution injections and record the chromatograms. Calculate the peak area RSD and retention time RSD of each component. The specific experimental results are as follows:

[0081] Table 3 Quantitative Limit Determination Result Table

[0082]

[0083]

[0084] It can be seen from the above table that the quantification limit of each impurity is not more than 0.05%; the retention time RSD of each impurity in the 6 quantification limit solutions is ≤0.6%, the peak area RSD is ≤7.2%, and the signa...

Embodiment 3

[0085] Embodiment 3 linear range investigation

[0086] Take the limit of quantification solution as the LOQ level linear solution.

[0087] Take the B-N impurity solution with a concentration of 200μg / mL, accurately measure 1.5ml, 2.5ml, 4ml, 5.0ml, and 7.5ml, put them in 25ml measuring bottles, dilute with diluent to make a scale, and use them as 30%, 50% %, 80%, 100%, 150% horizontal linear solution.

[0088] Concentration preparation of impurity A by increasing: Take the mixed solution of impurity A with a concentration of 15 μg / mL and ranitidine hydrochloride with a concentration of 10 μg / mL, accurately measure 8.5ml and 12ml, put them in 25ml measuring bottles respectively, and dilute to the mark with diluent , as the linear solution after addition.

[0089] Get above-mentioned solution, adopt the method measurement of embodiment 1, record chromatogram. Perform linear regression on the concentration (X) of the above solution and the corresponding peak area (Y), and ca...

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Abstract

The invention discloses a ranitidine hydrochloride detection method which comprises the following steps: (1) mixing ranitidine hydrochloride with a first mobile phase to obtain a test solution; (2) injecting the test solution into a liquid chromatograph, loading to a C18 chromatographic column, and performing gradient elution by using a first mobile phase and a second mobile phase to separate ranitidine hydrochloride in the test solution from impurities; and (3) testing the separated ranitidine hydrochloride and impurities through a detector to obtain a spectrogram. The effective separation ofranitidine hydrochloride and impurities is realized by changing the variety of mobile phases and the elution gradient of the mobile phases, so that the separation degree between spectral peaks is high, and a tailing factor is realized.

Description

technical field [0001] The invention relates to the technical field of liquid chromatography, in particular to a detection method and application of ranitidine hydrochloride. Background technique [0002] Ranitidine Hydrochloride Capsules is a selective H2 receptor antagonist, by acting on the H2 receptors on gastric parietal cells, it inhibits the basal secretion of gastric acid and the secretion after eating, thereby reducing the activity of gastric enzymes. At present, it is mainly used for the treatment of gastritis, gastric erosion, gastric ulcer and duodenal ulcer. In addition, it can also inhibit and kill Helicobacter pylori infection. [0003] At present, the methods for quantitative determination of ranitidine hydrochloride include capillary zone electrophoresis, fluorescence method, microfluidic chip method, spectrophotometry, high performance liquid chromatography, potentiometric titration and so on. The most commonly used method is high-performance liquid chroma...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74G01N30/86G01N30/88
CPCG01N30/02G01N30/06G01N30/34G01N30/74G01N30/8634G01N30/88G01N2030/8872G01N2030/884
Inventor 徐海霞
Owner FOSHAN SOIN PHARMA CO LTD
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