Detection method of sugammadex sodium

A technology of sugammadex sodium and a detection method, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of low sensitivity, cannot achieve effective separation of sugammadex sodium, and achieves good specificity and high accuracy. , the effect of high separation

Pending Publication Date: 2019-12-10
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Accurately detect the content of sugammadex sodium and its related impurities in the sugammadex sodium product or in the sugammadex sodium product obtained during the sugammadex sodium production process, for the quality of sugammadex sodi

Method used

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  • Detection method of sugammadex sodium
  • Detection method of sugammadex sodium
  • Detection method of sugammadex sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0079] Preparation of system suitability solution:

[0080] Dissolve the sugammadex sodium sample and impurities 1-20 in the same solvent as mobile phase A to obtain a mixed solution, wherein the concentration of sugammadex sodium in the mixed solution is 5 mg / ml, and the concentration of impurities 1-20 5 μg / ml respectively.

[0081] The system suitability solution is injected into the liquid chromatograph, wherein the chromatographic conditions are:

[0082] Column: C 18 Chromatographic column (YMC ODS-AQ 150×4.6mm, 3μm);

[0083] Mobile phase A: configure 20mmol / L potassium dihydrogen phosphate solution, and adjust the pH value to 2.3 with phosphoric acid;

[0084] Mobile phase B: acetonitrile;

[0085] UV detection wavelength: 200nm;

[0086] Flow rate: 0.8ml / min

[0087] Column temperature: 40°C;

[0088] Gradient elution program:

[0089] time (minutes) Mobile phase A(%) Mobile phase B(%) 0 83 17 10 83 17 40 80 20 50 75 25 ...

Embodiment 2

[0091] Example 2 is basically the same as Example 1, except that the pH value of mobile phase A is adjusted to 2.4 with phosphoric acid.

Embodiment 3

[0093] Example 3 is basically the same as Example 1, except that the pH value of mobile phase A is adjusted to 2.5 with phosphoric acid. Embodiment 1 to embodiment 3 each impurity separation situation is as shown in table 1:

[0094] Table 1

[0095]

[0096]

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Abstract

The invention relates to a method for detecting sugammadex sodium, which comprises the following steps of: respectively detecting a test sample solution and a reference substance solution by using a high performance liquid chromatograph under the chromatographic conditions that: a chromatographic column is a C18 chromatographic column; a mobile phase A is a phosphate buffer solution with the concentration of 5 mmol/L to 40 mmol/L or a phosphoric acid aqueous solution with the volume concentration of 0.1 percent to 1.0 percent, and the pH value of the mobile phase A is 2.0 to 2.9; a mobile phase B is acetonitrile; the column temperature of the chromatographic column is 30-45 DEG C; the flow rate is 0.6 ml/min to 1.2 ml/min; and the wavelength of the ultraviolet detection is 190 nm to 210 nm. According to the detection method of sugammadex sodium provided by the invention, sugammadex sodium related substances can be effectively separated, the sensitivity is high, the specificity is good,and the accuracy is high.

Description

technical field [0001] The invention relates to the field of analytical chemistry, in particular to a method for detecting sugammadex sodium. Background technique [0002] Sugammadex Sodium or Sugammadex was first developed by Organon Biosciences. In 2007, Organon was acquired by Schering-Plough, and in 2009, Schering-Plough merged with Merck. Sugammadex sodium is currently owned and sold by Merck, and has become a medium-sized product under Merck. In 2008, Sugammadex Sodium was launched in Europe for the first time, and then in Japan, the United States and other countries, and is now on the market in 75 countries. In 2016, Merck proposed the listing of Sugammadex Sodium in China. [0003] Sugammadex sodium is a modified γ-cyclodextrin, the first and only selective muscle relaxation antagonist (binding agent) (SRBA) successfully developed in 20 years, which encapsulates Aminosteroid non-depolarizing muscle relaxants block the relaxation effect, can quickly and predictably ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 白俊鹏王征肖宇孟秋月和潇夏金晶晶吴蕾吴青胡佰艳王琦王利春王晶翼
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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