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Method for simultaneously detecting relative retention time and peak purity of doxycycline and related substances in doxycycline hydrochloride

A technology of relative retention time and doxycycline hydrochloride, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of high price, inability to detect the peak purity value of doxycycline peak purity value, etc., to ensure effect of effectiveness

Pending Publication Date: 2020-07-24
扬州联博药业有限公司
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Problems solved by technology

At present, the prices of doxycycline standard products and related substance standard products on the market, such as: oxytetracycline standard products, metacycline standard products, β-doxycycline standard products, etc., are all very high. "The content of doxycycline hydrochloride content and related substances in "is still detected by UV detector, and the peak purity value of each reference substance and the doxycycline in doxycycline hydrochloride cannot be detected. peak purity value

Method used

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Embodiment l

[0030] A method for simultaneously detecting the relative retention time and peak purity of doxycycline and related substances in doxycycline hydrochloride, using HPLC and DAD to simultaneously detect the relative Retention time and peak purity value, wherein, HPLC adopts UV detector, UV detector and DAD detector are set up in series, the sample is first qualitatively detected by UV detector, and then peak purity is detected by DAD detector, the related substance is β- Doxycycline, metacycline, and oxytetracycline. Specifically include the following steps:

[0031] 1. HPLC-DAD detection conditions:

[0032] Column: XBridge C18;

[0033] Specification: 4.6×150mm, 5μm;

[0034] Flow rate: 1.0ml / min, column temperature: 35°C, UV detection wavelength 280nm, DAD detection wavelength 280nm, injection volume: 20μL;

[0035] Injection needle cleaning method: cleaning before injection, other conditions default;

[0036] Mobile phase preparation: [0.25mol / L ammonium acetate solutio...

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Abstract

The invention discloses a method for simultaneously detecting the relative retention time and the peak purity of doxycycline and related substances in doxycycline hydrochloride, and belongs to the technical field of detection of medicinal finished products. The method is characterized by adopting a mode of combining HPLC (High Performance Liquid Chromatography) and DAD (Diode Array Detector) to simultaneously detect the relative retention time and the peak purity of doxycycline and related substances in doxycycline hydrochloride; wherein the HPLC adopts a UV detector, the UV detector and the DAD are arranged in series, a sample is firstly subjected to qualitative detection through the UV detector, and then subjected to peak purity detection through the DAD; the related substances include beta-doxycycline, metacycline, and oxytetracycline. The method of the invention can detect the peak purity values of the doxycycline, the beta-doxycycline, the metacycline and the oxytetracycline whiledetecting the relative retention time of the doxycycline and the related substances in the doxycycline hydrochloride.

Description

technical field [0001] The invention belongs to the technical field of detection of finished pharmaceutical products, and in particular relates to a method for simultaneously detecting the relative retention time and peak purity of doxycycline and related substances in doxycycline hydrochloride. Background technique [0002] Doxycycline hydrochloride is one of the applicant's main products, and its quality control requirements are strictly in accordance with relevant laws and regulations. At present, the prices of doxycycline standard products and related substance standard products on the market, such as: oxytetracycline standard products, metacycline standard products, β-doxycycline standard products, etc., are all very high. "The content of doxycycline hydrochloride and related substances in "is still detected by UV detector, and the peak purity value of each reference substance and the doxycycline in doxycycline hydrochloride cannot be detected. Peak purity value. Con...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8675G01N2030/047
Inventor 康飞刚史俊平李志兵张新慧
Owner 扬州联博药业有限公司
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