The assay method of lansoprazole chloride in lansoprazole
A technology for lansoprazole and chloride, applied in the field of determination of lansoprazole chloride in lansoprazole, can solve the problems of low detection method sensitivity and failure to meet control requirements, and achieve good specificity and accuracy high effect
Active Publication Date: 2017-01-11
桂林华信制药有限公司
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Problems solved by technology
The sensitivity of the detection method for related substances is not high, and the detection limit is about 700ppm, which is far from meeting the control requirements for genotoxic substances in lansoprazole in the "Guidelines on the Limits of Genotoxic Impurities"
[0005] Have not disclosed the detection method that is specially used in the Lansoprazole chloride at present, so urgently need to develop new method, be specially used in the content determination of Lansoprazole in Lansoprazole
Method used
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[0058] The principles and features of the present invention are described below in conjunction with the accompanying drawings, and the examples given are only used to explain the present invention, and are not intended to limit the scope of the present invention.
[0059] instrument:
[0060] High performance liquid chromatography;
[0061] One hundred thousandth electronic balance;
[0062] Reagent:
[0063] Disodium hydrogen phosphate anhydrous, AR grade;
[0064] Phosphoric acid, HPLC grade;
[0065] Acetonitrile, HPLC grade;
[0066] water, purified water.
[0067] Chromatographic conditions:
[0068] Chromatographic column: Aminohexadecyl silica gel column (5μm, 250×4.6);
[0069] Mobile phase: acetonitrile: pH6.2 phosphate buffer = 35:65. The preparation method of pH6.2 phosphate buffer solution is to add 1.41g of anhydrous disodium hydrogen phosphate to 1000ml of water, and adjust the pH to 6.2 with phosphoric acid.
[0070] Detection wavelength: 210nm;
[0071]...
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The invention relates to a determination method for lanso chloride in lansoprazole. By adopting an impurity reference substance external standard method in a high performance liquid chromatography, a chromatographic column is an inverse extremely strong polar column, a moving phase is an acetonitrile-pH6.2-6.5 phosphate buffer, a diluent is an acetonitrile-pH10.5 phosphate buffer, and the detection wavelength is 210nm. The method provided by the invention is a mainstream high performance liquid chromatography (HCLP) which is extremely high in sensitivity. Experiments show that the limit of the detection is 0.5ppm and fully reaches the control demand that gene poisonous substances in the lansoprazole are 8ppm according to a Genotoxic Impurity Limit Guide, the specificity is good and the accuracy is high. Through methodology validation in light of an ICH guiding principle Q2b methodology, results meet the requirements of the guiding principle.
Description
technical field [0001] The invention relates to drug detection, in particular to the detection of genotoxic impurities in lansoprazole, more specifically to a method for measuring lansoprazole chloride. Background technique [0002] Genotoxic impurities are in vivo and in vitro experiments with DNA reactive substances as the main research object. If they are found to be destructive to DNA, they can be called genotoxic. According to current research practice, compounds with in vivo genotoxicity have the potential to cause DNA damage at any exposure dose, and this damage has the potential to initiate tumors. [0003] At present, the control of genotoxic impurities in European and American countries is relatively strict. All drugs that may contain genotoxic impurities are required to be tested for the content of genotoxic impurities, and the "Guidelines for the Limits of Genotoxic Impurities" has been issued. According to the EMA "Guidelines on the Limits of Genotoxic Impuriti...
Claims
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IPC IPC(8): G01N30/02
Inventor 时孟军于利庆叶家强唐世锭陈如黎德南张晓程
Owner 桂林华信制药有限公司