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Double phosphonic acid salt medicaments and ion chromatographic fractionation analysis method of impurity anion thereof

A technology for separation and analysis of bisphosphonates, which is applied in the field of analysis of bisphosphonates, can solve problems such as cumbersome operations, and achieve the effects of expanding the scope of application and simplifying the process flow.

Inactive Publication Date: 2008-08-27
ZHEJIANG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The content determination methods of bisphosphonates are commonly used acid-base potentiometric titration, molybdenum yellow or molybdenum blue colorimetry, and inductively coupled plasma method, but these methods cannot be used to determine anion impurities in drugs; bisphosphonates are a A substance with a high boiling point needs to be derivatized when it is analyzed by gas chromatography; and because there is no chromophore in the molecular structure of this type of drug, it needs to be detected by ultraviolet detectors and fluorescence detectors after derivatization, and the operation is very cumbersome.

Method used

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  • Double phosphonic acid salt medicaments and ion chromatographic fractionation analysis method of impurity anion thereof
  • Double phosphonic acid salt medicaments and ion chromatographic fractionation analysis method of impurity anion thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] This example analyzes alendronate sodium and five common anions in alendronate sodium tablets

[0036] Instruments used: Dionex ICS 2000 ion chromatograph (Dionex, USA); EG50 eluent generator; DS6 conductivity detector; Chromeleon 6.5 chromatography workstation; IonPac AG11 guard column (50mm×2mm); IonPac AS11 separation column (250mm×2mm) 2mm); 25μL injection volume.

[0037] Suppressor: Dionex AAES self-regenerating suppressor;

[0038] Eluent: KOH solution, using gradient elution. At 0-2 minutes, the concentration of potassium hydroxide is 1mmol / L; at 2-12 minutes, the concentration is 1mmol / L-18mmol / L; at 12.01-17.00min, the concentration of potassium hydroxide is 1mmol / L.

[0039] Analysis steps:

[0040] ① Baseline surveying and mapping

[0041] The eluent is pumped into the chromatographic separation column to achieve equilibrium, and the eluent output from the chromatographic separation column enters the suppressor, and when it flows into the conductivity fl...

Embodiment 2

[0047] This embodiment is to analyze the etidronate sodium content in the rabbit plasma.

[0048] Apparatus used: same as Example 1.

[0049] Suppressor: same as embodiment 1.

[0050] Eluent: KOH solution. The gradient elution scheme is: when 0-2min, the concentration of 3mmol / L potassium hydroxide is selected; for 2-12min, the concentration is 1mmol / L-30mmol / L potassium hydroxide; L of potassium hydroxide.

[0051] The analysis steps are the same as in Example 1. The plotted spectrum is shown in Figure 2.

[0052] The analysis result is: the content of etidronate sodium in the plasma sample collected 1 hour after the rabbit took the medicine is: 5.0 μg / ml

Embodiment 3

[0054] This embodiment is to analyze the content of risedronate sodium in physiological saline.

[0055] Apparatus used: same as Example 1.

[0056] Suppressor: Dionex ASRS-ULTRA self-regenerating suppressor.

[0057] Eluent: KOH solution. The gradient elution scheme is: at 0-3 minutes, the concentration of potassium hydroxide is 20mmol / L; at 3.01-8.00min, the concentration is 45mmol / L; at 8.01-15.00min, the concentration of potassium hydroxide is 20mmol / L.

[0058] The analysis steps are the same as in Example 1. The plotted spectrum is shown in Figure 3.

[0059] The analysis results are as follows: the normal saline matrix does not interfere with the determination of risedronate sodium, and the peak shape of the sample chromatographic peak is very good; the average recovery rate of risedronate sodium is 106.4%

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Abstract

The invention discloses a double phosphonate medicine and a method for the isolation analysis of the ion chromatography for impurity negative ions thereof; the method includes steps of the base line mapping, the sample injection, the ion exchange, the elution and the detection and analysis of the restraining electric conduction; the method can be used to measure the contents of the double phosphonate and the impurity negative ions in double phosphonate medicines, plasmas, normal saline substrates and glucose substrates.

Description

technical field [0001] The invention relates to an analysis method for bisphosphonate drugs (including alendronate sodium, etidronate sodium, risedronate sodium, zoledronic acid, etc.), in particular to separation by gradient elution and inhibition of conductivity detection An ion chromatography method for the detection of bisphosphonate drugs. Background technique [0002] Bisphosphonates are new bone resorption inhibitors developed in the 1980s and have been successfully used in the treatment of bone-calcium metabolism diseases and some bone-related diseases. The content determination methods of bisphosphonates are commonly used acid-base potentiometric titration, molybdenum yellow or molybdenum blue colorimetry, and inductively coupled plasma method, but these methods cannot be used to determine anion impurities in drugs; bisphosphonates are a A substance with a high boiling point needs to be derivatized when it is analyzed by gas chromatography; and because there is no ...

Claims

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Application Information

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IPC IPC(8): G01N30/96
Inventor 张培敏朱岩焦霞
Owner ZHEJIANG UNIV
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