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Method of measuring related substances in nicorandil tablets by HPLC (high performance liquid chromatography) correction factor process

A technology of Nicorandil tablets and related substances, which is applied in the field of medicine and can solve the problems of poor understanding of Nicorandil tablets, poor specificity, and inability to effectively separate and analyze them.

Inactive Publication Date: 2019-03-01
BEIJING INST FOR DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current standard for Nicorandil tablets in China is the national standard WS-10001-(HD-0151)-2002 (National Pharmacopoeia Commission. National Drug Standards Chemical Drug Local Standards Rise National Standard Volume II. Beijing: China Medical Science and Technology Press, 2002, 61), did not include the relevant substance inspection items, and its content determination method was the ultraviolet E value method, which was poor in specificity, resulting in a lack of in-depth understanding of the relevant substances in Nicorandil tablets in China for a long time
Although the British Pharmacopoeia currently contains inspection items for related substances in Nicorandil tablets using the HPLC method, and the method has been changed in its 2017 edition, the old and new methods (The British Pharmacopoeia Commission Office.BP2016.London:The stationery on behalf of MHRA, 2016, 905-907; The British Pharmacopoeia Commission Office.BP2017.London: The stationery on behalf of MHRA, 2017, 937-939) cannot effectively separate and analyze the related substances of domestic nicorandil tablets, especially For example, impurity A, impurity B, impurity C, impurity D, impurity E and other impurities in the typical process mentioned in this article, and the effective separation of these impurities is of great significance to the quality control of domestic Nicorandil tablets, such as for domestic The relevant substances in Nicorandil tablets are effectively separated and analyzed, and used for the consistency evaluation of generic drugs, which is of great significance for the quality consistency analysis of domestic generic drugs

Method used

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  • Method of measuring related substances in nicorandil tablets by HPLC (high performance liquid chromatography) correction factor process
  • Method of measuring related substances in nicorandil tablets by HPLC (high performance liquid chromatography) correction factor process
  • Method of measuring related substances in nicorandil tablets by HPLC (high performance liquid chromatography) correction factor process

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Experimental program
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Embodiment 1

[0058] Example 1: Methodological research on the determination of related substances in Nicorandil tablets using the HPLC correction factor method

[0059] 1. Methods and Results

[0060] Nicorandil reference substance, impurity A reference substance (China Institute for Food and Drug Control), impurity B, C, D working reference substance (self-made), impurity E working reference substance (Canada TLC company), Nicorandil tablet samples All are derived from market sampling.

[0061] The chromatographic conditions adopt Atlantis T3C18 chromatographic column, (4.6×250mm, 5μm), with trifluoroacetic acid-triethylamine-tetrahydrofuran-water (3:5:3:989) as mobile phase A, with water: tetrahydrofuran: triethylamine : Trifluoroacetic acid (972:20:5:3) is the mobile phase B, the gradient elution is carried out in the following table, the flow rate is 1.2ml / min, the column temperature is 25°C, and the detection wavelength is 262nm.

[0062] time (minutes)

Mobile phase A...

Embodiment 2

[0083] Embodiment 2: Determination of Nicorandil Tablet Related Substances Using HPLC Calibration Factor Method

[0084] Use high-performance liquid chromatography to detect the related substances in the Nicorandil tablet, and the operation steps are as follows:

[0085] (1) measure according to the specification in the high-performance liquid chromatography that Chinese Pharmacopoeia 2015 edition four general rules 0512 carries;

[0086] (2) Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as a chromatographic column (this example uses WatersAtlantis T3 column, 250 × 4.6mm, 5μm), with trifluoroacetic acid-triethylamine - Tetrahydrofuran-water (3:5:3:989) is mobile phase A, water: tetrahydrofuran: triethylamine: trifluoroacetic acid (972:20:5:3) is mobile phase B, and the gradient is shown in the table below The elution program is gradient elution, the flow rate is 1.2ml / min, the column temperature is 25°C, and the detection wave...

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Abstract

The invention relates to a method of measuring related substances in nicorandil tablets by HPLC (high performance liquid chromatography) correction factor process. The method performs measuring according to specifications in high performance liquid chromatography set forth in the general principle 0512 of Chinese Pharmacopoeia 2015 edition volume IV; C18 chromatographic column is used, trifluoroacetic acid-triethylamine-tetrahydrofuran-water mixed solution is used as a mobile phase to carry out measuring; impurities that may be quantitatively measured include impurity A, impurity B, impurity C, impurity D, impurity E and related known substances; the method has good methodological properties, such as wide linear range of test, good linearity, small detection limit and quantification, and good precision.

Description

technical field [0001] The invention belongs to the technical field of medicine, relates to a quality control method for medicines, in particular to a method for detecting related substances in nicorandil tablets, and more particularly to a method for determining related substances in nicorandil tablets using HPLC correction factor method . The method of the invention can reliably and simultaneously perform quantitative detection of many related substances in the nicorandil tablet, such as impurity A, impurity B, impurity C, impurity D, and impurity E, and has excellent methodological performance. Background technique [0002] Nicorandil, chemical name N-(2-hydroxyethyl)-nicotinamide nitrate, N-[2-(Nitrooxy)ethyl]-3-pyridinecarboxamide, molecular formula C 8 h 9 N 3 o 4 , molecular weight 211.17, its chemical structural formula is: [0003] [0004] Nicotinamide belongs to nitrate compounds, is an ATP-sensitive potassium channel opener, and is mainly used clinically ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884G01N2030/8872
Inventor 吴兆伟吴斌杜凯王琳杨文良戴红胡琴张喆王铁松吴科春
Owner BEIJING INST FOR DRUG CONTROL
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