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Detection method of nitrosamine impurities in candesartan cilexetil

A technology of candesartan cilexetil and detection method, applied in the field of drug analysis, to achieve the effect of ensuring drug safety and good system adaptability

Inactive Publication Date: 2020-12-25
HINYE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there are many detection methods for nitrosamine impurities in valsartan and its preparations, and only two kinds of nitrosamine impurities in valsartan (N-nitrosodimethylamine (NDMA) and N- Nitrosodiethylamine (NDEA)) has been detected and analyzed; the detection of impurities in candesartan cilexetil is mainly based on azide compounds, and there is almost no research on nitrosamine impurities, and the current liquid chromatography-mass spectrometry There is no simple and general analysis method for various nitrosamine compounds in the method

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  • Detection method of nitrosamine impurities in candesartan cilexetil

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[0028] In order to describe the technical solution of the present invention more clearly and completely, the present invention will be further described in detail through specific examples below. It should be understood that the specific examples described here are only used to explain the present invention, and are not used to limit the present invention. Various changes can be made within the scope defined by the rights of the present invention.

[0029] The reagent information that the present invention adopts is as follows:

[0030] The sample candesartan cilexetil was collected from Tiandi Hengyi Pharmaceutical Co., Ltd., the batch number is 190901;

[0031] The content of the reference substance N-methylbutyl nitrosamine (NMBA) is 98%; the content of N-dimethyl nitrosamine (NDMA) is 99.2%; the content of N-diethyl nitrosamine (NDEA) It is 99.6%; The content of N-dibutyl nitrosamine (NDBA) is 99%; The content of N-diisopropyl nitrosamine (NDIPA) is 99.8%; N-ethyl isoprop...

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Abstract

The invention discloses a detection method of nitrosamine impurities in candesartan cilexetil. The method comprises the following steps of: S1, preparing a solution: respectively preparing a test solution and a standard curve solution; and S2, detecting: detecting and analyzing the test solution and the standard curve solution in the step S1 by adopting liquid chromatography and mass spectrometry.According to the detection method disclosed by the invention, nitrosamine compounds in the candesartan cilexetil can be more comprehensively detected, and simultaneous detection of seven nitrosaminecompounds can be realized on the premise of adopting one ion source, so that the quality and medication safety of the candesartan cilexetil are ensured. The detection limit of the detection method fordetecting the nitrosamine compounds in the candesartan cilexetil can reach a trace level; the detection method disclosed by the invention has good system adaptability, specificity, quantification limit and detection limit, linearity and range, accuracy, precision, durability and solution stability on detection of seven nitrosamines in the candesartan cilexetil.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for detecting nitrosamine impurities in candesartan cilexetil. Background technique [0002] Nitrosamine compounds are strong carcinogens and are highly mutagenic and carcinogenic to humans. None of the animals tested could tolerate nitrosamines without causing cancer. Not only a long-term low dose can cause cancer in animals or humans, but also only one high-dose shock can cause cancer. [0003] Candesartan cilexetil is an angiotensin Ⅱ receptor blocker (ARB), developed by Takeda Corporation of Japan, first launched in Sweden in 1998, and became the first ARB available in Japan for the treatment of chronic heart failure in 2005. Candesartan cilexetil has high selectivity and affinity for angiotensin Ⅱ subtype AT1 receptor, so it has better antihypertensive effect and smaller and less side effects. [0004] The "valsartan incident" in recent years has aroused people's att...

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/047
Inventor 文鑫旺王洁
Owner HINYE PHARM CO LTD
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