Method for detecting content of rupatadine fumarate by liquid chromatography

A rupatadine fumarate and liquid chromatography technology, which is applied in the field of liquid chromatography detection of rupatadine fumarate content, achieves the effect of simple and fast method, high analytical sensitivity and fast analysis

Inactive Publication Date: 2012-09-19
FOSHAN DAYI TECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention aims at the problems existing in the determination of rupatadine fumarate content at present, and provides a liquid chromatography detection method for rupatadine fumarate content which solves the above problems

Method used

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  • Method for detecting content of rupatadine fumarate by liquid chromatography
  • Method for detecting content of rupatadine fumarate by liquid chromatography
  • Method for detecting content of rupatadine fumarate by liquid chromatography

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Experimental program
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Effect test

Embodiment 1

[0028] Detection instrument parameters

[0029]

[0030] Detection steps:

[0031] Take about 10mg of rupatadine fumarate, put it in a 100ml measuring bottle, add blank solution (mobile phase A: mobile phase B=20:80) to dissolve and dilute to the mark, shake well, and use it as the test solution.

[0032] Get blank solution and need testing solution respectively, carry out high-performance liquid chromatography analysis according to above-mentioned conditions, record chromatogram, the result is shown in appendix respectively. figure 1 And attached figure 2 .

[0033] The result shows: the blank solution chromatogram figure 1 There are no interfering peaks at the retention time of the analyte. The chromatogram of the test solution figure 2 The chromatogram with a retention time of 7.47min is the main peak of rupatadine fumarate. The chromatogram shows that rupatadine fumarate and other impurity peaks can be well separated under the same chromatographic conditions. The...

Embodiment 2

[0035] Take an appropriate amount of rupatadine fumarate tablets, approximately equivalent to 10 mg of rupatadine fumarate, put them in two 100ml bottles, add an appropriate amount of blank solution (mobile phase A: mobile phase B=20:80, v / v) , Shake to dissolve, then dilute to volume with blank solution, shake well, filter, and the filtrate is used as the test solution. Get need testing solution, analyze and detect according to the condition of embodiment 1, and carry out adjuvant blank test and need testing solution test with method, the results see image 3 and Figure 4 .

[0036] image 3 Prove that the blank of excipients does not interfere with the determination, Figure 4 It shows that this method can be used for the quality detection of rupatadine fumarate preparation.

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Abstract

The invention relates to the technical field of content detection of biomedical preparations, in particular to a method for detecting the content of rupatadine fumarate by liquid chromatography. According to the method, a chromatographic column is used, gradient elution is adopted, a flowing phase consists of a flowing phase A and a flowing phase B, the flowing phase A is a buffer solution which consists of 0.05 to 0.30 volume percent triethylamine and 0.01 to 0.05mol/L phosphate and phosphoric acid and has the pH of 3.0 to 5.0, and the flowing phase B is an organic modifier. By the method, related substances such as the rupatadine fumarate are controlled, and the content of the rupatadine fumarate can be accurately measured, the quality of the rupatadine fumarate is controllable, the method is simple and quick, can be used for the quality control of the rupatadine fumarate and has great practical significance for quality control in the synthesis and preparation processes, analysis sensitivity is high, a result is accurate and reliable, the quality of Chinese herbal medicines and a preparation is controllable, and the requirement of quick analysis during production is met.

Description

technical field [0001] The invention relates to the technical field of content detection of biomedical preparations, in particular to a liquid chromatography detection method for the content of rupatadine fumarate. Background technique [0002] Rupatadine fumarate (Rupatadine fumarate), the molecular formula is C 30 h 30 N 3 ClO 4 , the molecular weight is 531.5, and the structural formula is as shown in Formula 1: [0003] [0004] formula one [0005] Rupatadine fumarate has dual effects of antihistamine and platelet activating factor (PAF). Studies have shown that allergic and inflammatory diseases are multifactorial and complex processes resulting from the production and release of many different mediators. Histamine is the most inflammatory mediator contained in the early stage of allergic reaction and when the symptoms of such diseases appear. It is released by antigen-activated mast cells and basophils. Symptoms of these diseases such as sneezing, nasal itc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 陈宝林雍智全闻亚磊阴元魁唐良伟庄东杰
Owner FOSHAN DAYI TECH LTD
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