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Method for separating and detecting minodronic acid

A technology of minodronic acid and elution method is applied in the field of separation and detection of minodronic acid, which can solve the problems of low number of theoretical plates, inability to accurately evaluate the quality of minodronic acid, and less detection of the number of impurity peaks.

Inactive Publication Date: 2018-01-05
TIANJIN HANKANG PHARMA BIOTECH
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AI Technical Summary

Problems solved by technology

[0003] The detection conditions for minodronic acid in the prior art have poor separation of impurities, fewer impurity peaks are detected, the number of theoretical plates is low, the quality of minodronic acid cannot be accurately evaluated, and the data lacks authenticity and accuracy

Method used

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  • Method for separating and detecting minodronic acid
  • Method for separating and detecting minodronic acid

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Experimental program
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Embodiment 1

[0029] 1) Instruments and conditions

[0030] High-performance liquid chromatography: Shimadzu LC-2010AHT; filler: C18 (150mm×4.6mm, 5μm); mobile phase A: take 1.6g of sodium dihydrogen phosphate and 1.2g of sodium decanesulfonate, add 1000ml of water to dissolve, and use Adjust the pH value to 2.5 with phosphoric acid, mobile phase B: methanol; adopt linear gradient elution method; gradient elution method is as follows:

[0031]

[0032] The column temperature is 30°C; the flow rate is 1.0ml / min; the detection wavelength is 215nm; the injection volume is 10μl.

[0033] 2) Experimental steps

[0034] Take 25mg of minodronic acid fine powder, accurately weigh it, put it in the same 50ml measuring bottle, add methanol to dissolve and dilute to the mark, shake well, and use it as a mixed solution. Carry out HPLC analysis according to above-mentioned condition, record chromatogram, the result sees figure 1 . exist figure 1 Among them, the solvent peak and the excipient pea...

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Abstract

The application relates to a method for separating and detecting minodronic acid. The method adopts a reverse-phase chromatographic column through high performance liquid chromatography, and uses a buffer solution of pH=2-7.5 containing sodium alkylsulfonate as mobile phase A, and Methanol or acetonitrile was used as mobile phase B, the detection wavelength was 215nm, and linear gradient elution was used for separation and detection.

Description

technical field [0001] The application relates to a method for separating and detecting drugs, in particular to a method for separating and detecting minodronic acid. Background technique [0002] Minodronic acid tablets were jointly developed by Japan Ono Pharmaceutical Co., Ltd. and Japan Astellas Pharmaceutical Co., Ltd., and were launched in the Japanese Ministry of Health and Welfare in January 2009. They can be used as first-line drugs for the treatment of osteoporosis. Lendronic acid and minodronic acid have similar efficacy, but the dosage is significantly lower (alendronic acid is 10mg / day, minodronic acid is 1mg / day), improving patient compliance and reducing diphosphate Salt common gastrointestinal adverse reactions. [0003] The detection conditions for minodronic acid in the prior art have poor separation of impurities, fewer impurity peaks are detected, and the number of theoretical plates is low. The quality of minodronic acid cannot be accurately evaluated, ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 严洁王志凤
Owner TIANJIN HANKANG PHARMA BIOTECH
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