Method for detecting N-nitroso amlodipine impurity in perindopril amlodipine tablet

The detection of N-nitrosoamlodipine impurities in perindoprimelamlodipine tablets by high performance liquid chromatography solves the gaps in the detection methods in the prior art, and realizes efficient, specific and repeatable detection of impurities, ensuring the accuracy and reliability of the detection results.

CN120468348APending Publication Date: 2025-08-12WUHAN BORUIHENG MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202510785319.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-06-12
Publication Date
2025-08-12

AI Technical Summary

Technical Problem

The prior art lacks a method for detecting N-nitrosoamlodipine impurities in perindopril amlodipine tablets, which leads to the inability to effectively control its content.

Method used

The N-nitrosoamlodipine impurities in perindoprimelamlodipine tablets were detected by high performance liquid chromatography. A Phenomenex Kinetex 2.6μm C18 100A chromatography column was used. Mobile phase A was an aqueous solution containing 0.1% (v/v) formic acid and 2mM ammonium acetate, and mobile phase B was acetonitrile containing 0.1% (v/v) formic acid, and the column temperature was 45°C, and the impurity content was analyzed by the external standard method.

Benefits of technology

The efficient, specific, systematic applicability and repeatability detection of N-nitrosoamlodipine impurities in perindoprimelamlodipine tablets is achieved, ensuring the accuracy and reliability of the test results.

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Abstract

The invention relates to the technical field of medicine detection, in particular to a method for detecting N-nitroso amlodipine impurities in perindopril amlodipine tablets, which comprises the following steps: S1, preparing a test solution; s2, preparing a reference substance solution; the conditions of high performance liquid chromatography are as follows: Phenomenex Kinetex 2.6 [mu] m C18 100A is taken as a chromatographic column, a Phenomenex guard column is taken as a pre-column, an aqueous solution containing 0.1% (v / v) formic acid and 2mM ammonium acetate is taken as a mobile phase A, acetonitrile containing 0.1% (v / v) formic acid is taken as a mobile phase B, and the column temperature is 45 DEG C; and S4, performing chromatographic analysis. According to the present invention, the N-nitroso amlodipine impurity in the perindopril amlodipine tablet is determined through the high performance liquid chromatography, and the method has advantages of good specificity, good system applicability and good repeatability.
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