High performance liquid chromatography analysis method for nitrosamines in ranitidine drugs

A high-performance liquid chromatography and ranitidine technology, applied in the field of drug testing, can solve the problems of difficulty in data reproduction and accurate determination, harsh conditions, conjugate elution, etc., and achieve stable test results and high accuracy. , good reproducibility

Pending Publication Date: 2021-03-19
JIANGSU HI STONE PHARMA
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Problems solved by technology

Nitrosamines (NDMA) basically have the phenomenon of conjugate elution in the existing detection methods. The conditions in the experiment are relatively harsh, and it is very difficult to reproduce the data and accurately determine its content.

Method used

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  • High performance liquid chromatography analysis method for nitrosamines in ranitidine drugs

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Embodiment 1

[0033] The invention discloses a high-performance liquid chromatography analysis method for nitrosamines in ranitidine drugs. Taking ranitidine hydrochloride as a sample, the N-dimethylnitrosamine (NDMA) in it is tested. content as an example,

[0034] Including the following steps:

[0035] (1) Sample treatment: Take about 1 g of ranitidine hydrochloride raw material, dry it, and then grind it into powder in a dry mortar. Keep dry during the grinding process to prevent moisture absorption. Because ranitidine hydrochloride is highly hygroscopic, drying treatment first, and then grinding the ingredients under dry conditions can make the N-dimethylnitrosamine contained in it better dissolved into the diluent;

[0036] (2) Preparation of sample solution: Immediately after grinding, accurately weigh 0.5 g of ground ranitidine hydrochloride powder and add it to a 10 ml container with a stopper to ensure that the powder does not remain on the container wall, and then accurately add...

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Abstract

The invention discloses a high performance liquid chromatography analysis method for nitrosamine substances in ranitidine drugs. The method comprises the following steps of (1) sample treatment; (2) preparing a sample solution; (3) preparing a control solution; and (4) chromatographic analysis. The ranitidine drug is subjected to drying and grinding treatment, low-temperature configuration under asealing condition, filtration before testing and other process conditions are set, so on one hand, stability and accuracy of an N-dimethyl nitrosamine test result are ensured; on the other hand, pollution of the sample to the chromatographic system is greatly reduced, the later use and maintenance are reduced, and maintenance cost is saved; on the basis of sample treatment, test analysis can be carried out by using a conventional high performance liquid chromatograph, accuracy is high, result reproducibility is good, a large amount of capital investment is not needed, cost is saved, and the method is suitable for industrial production and application and wide in market prospect.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a high performance liquid chromatography analysis method for nitrosamines in ranitidine drugs. Background technique [0002] Since ranitidine drugs were found to contain a certain amount of nitrosamines, such as N-dimethylnitrosamine (NDMA), the US FDA and the China Food and Drug Inspection Institute have formulated a variety of regulations for this substance. Liquid-mass-mass method is used for detection. Without exception, all these determination methods require the use of triple quadrupole mass spectrometers, which have very high requirements for the sensitivity of the instrument. Generally, laboratories do not have the corresponding detection equipment, and the use of such instruments requires high requirements. , It is difficult to maintain, and it is not suitable for most enterprises or scientific research institutes to conduct daily quantitative analysis of such sub...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8675
Inventor 史加桂孙征宇卫耿虎
Owner JIANGSU HI STONE PHARMA
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