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Lafutidine tablet content detection method

A detection method, the lafutidine technology, is applied in the field of lafutidine tablet content detection, which can solve the problems of large material consumption, non-compliance with the separation requirements, cumbersome operating procedures, etc., and achieve less material consumption and accurate The effect of high degree and optimized chromatographic conditions

Pending Publication Date: 2022-03-01
湖北舒邦药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The embodiment of the present application provides a method for detecting the content of lafutidine tablets to solve the problem of using the internal standard method to determine the content of lafutidine tablets in related technologies, which requires large material consumption, cumbersome operating procedures and inconsistent separation. Asked technical questions

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  • Lafutidine tablet content detection method
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  • Lafutidine tablet content detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] 1. Preparation of sample solution

[0036] Prepare a lafutidine sample solution with a concentration of 0.1 mg / ml;

[0037] 2. Content detection

[0038] The detection conditions are:

[0039] The mobile phase is a mixed solution of acetonitrile / sodium pentanesulfonate-phosphate buffer solution with a volume ratio of 15:85;

[0040] The column temperature is 40°C;

[0041] The detection wavelength is 275nm.

[0042] Under the above-mentioned chromatographic conditions, use high-performance liquid chromatography external standard method to detect the content of the sample solution, the injection volume is 25 μl, and the detection diagram is as follows figure 1 shown.

[0043] from figure 1 It can be seen that even if the sample concentration of lafutidine is reduced, the peak shape detected by high performance liquid chromatography is still good.

Embodiment 2

[0045] 1. Preparation of blank excipient solution

[0046] Take an appropriate amount of blank adjuvant according to the prescription ratio of lafutidine tablet, place it in a 100ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake up, and filter with a filter membrane to prepare a blank adjuvant solution.

[0047] 2. Prepare mixed solution

[0048] Take appropriate amount of lafutidine, lafutidine isomers and impurity reference substance, and configure it into a mixed solution.

[0049] 3. Content detection

[0050] Chromatographic conditions:

[0051] The mobile phase is a mixed solution of acetonitrile / sodium pentanesulfonate-phosphate buffer solution with a volume ratio of 15:85;

[0052] The column temperature is 40°C;

[0053] The detection wavelength is 275nm;

[0054] The chromatographic column is CAPCELL PAK C18 (150×4.6mm, 3μm);

[0055] Adjust the flow rate so that the time for the main peak to emerge is about 15 minutes.

[0056] W...

Embodiment 3

[0061] 1. Prepare the test solution

[0062] Accurately weigh 20 tablets of the test product, grind them finely, accurately weigh an appropriate amount of fine powder, put the grinded fine powder equivalent to 10 mg of lafutidine in a 100ml measuring bottle, add an appropriate amount of mobile phase, and shake to make the lafutidine Futidine was dissolved and diluted to the mark, shaken up, filtered, and the filtrate was taken as the test solution, and 6 parts of the test solution were prepared in the same way.

[0063] 2. Prepare the reference solution

[0064] Get the appropriate amount of lafutidine reference substance, add mobile phase to dissolve and dilute the reference substance solution prepared.

[0065] 3. Content detection

[0066] Chromatographic conditions:

[0067] The mobile phase is a mixed solution of acetonitrile / sodium pentanesulfonate-phosphate buffer solution with a volume ratio of 15:85;

[0068] The column temperature is 40°C;

[0069] The detection...

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Abstract

The invention relates to the technical field of oral solid preparation analysis, and provides a method for detecting the content of lafutidine tablets, which adopts a high performance liquid chromatography to detect the content of each component in the lafutidine tablets. Chromatographic conditions of the high performance liquid chromatography are as follows: a mobile phase is a mixed solution of acetonitrile and a phosphate buffer solution added with sodium pentanesulfonate in a volume ratio of (10: 90)-(20: 80); the column temperature is 35-45 DEG C; the detection wavelength is 250nm to 300nm, and the preparation range of detectable sample concentration is 50mu g / ml to 150mu g / ml. According to the method for detecting the content of the lafutidine tablets, the content of each substance in the lafutidine tablets is measured through a high performance liquid chromatography external standard method, chromatographic conditions are optimized, efficient detection of the content of each substance in the lafutidine tablets is achieved, the method is good in reproducibility, easy to operate, high in accuracy and low in requirement for a chromatographic column, and the method is suitable for industrial production. The separation degree, the durability and the reproducibility are good.

Description

technical field [0001] The application relates to the technical field of analysis of oral solid preparations, in particular to a method for detecting the content of lafutidine tablets. Background technique [0002] Lafutidine Tablets is a new generation of histamine H 2 Receptor blockers can continuously inhibit the basal secretion and nocturnal secretion of gastric acid and pepsin, and the secretion of gastric acid caused by stimulating factors such as tetragastrin, uracholine, and gastric dilatation. Lafutidine acts on the capsaicin-sensitive afferent nerve of the digestive tract mucosa, mediates the release of calcitonin gene-related peptide and nitric oxide, increases mucosal blood flow, promotes mucus secretion, and promotes mucosal epithelial regeneration, thereby protecting the digestive tract mucosa , to resist gastric acid, alcohol, bile and other stimulating factors on the mucosal damage, promote ulcer healing, and prevent ulcer recurrence. [0003] At present, t...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 周明霞黄晶李守明张洁
Owner 湖北舒邦药业有限公司
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