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Determination method for related substances in glimepiride bulk drug

A technology of related substances and determination methods, which is applied in the field of determination of related substances in glimepiride raw materials, can solve the problems of inability to fully react, detect a small amount of impurities, and poor specificity, and achieve high separation, high accuracy, The effect of easy operation

Active Publication Date: 2022-08-02
BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method has strong specificity, high accuracy, good durability, and is easy to operate. It can solve the problems of poor specificity, small amount of detected impurities, and inability to fully reflect the related substances of glimepiride API. This method can be applied to the Limepiride raw material drug quality control

Method used

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  • Determination method for related substances in glimepiride bulk drug
  • Determination method for related substances in glimepiride bulk drug
  • Determination method for related substances in glimepiride bulk drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1: System applicability of the assay method of the present invention

[0025] 1. Solution Preparation

[0026] Diluent: 80% acetonitrile in water

[0027] Test solution: take an appropriate amount of the test, accurately weigh it, add diluent to dissolve and dilute to make a test solution with a concentration of 20 mg / mL.

[0028] Reference solution: Precisely measure 1mL of the test solution, put it in a 100mL volumetric flask, dilute it to the mark with diluent, shake well, and use it as a control solution.

[0029] The preparation of each impurity positioning solution: take the impurity 1, impurity 2, impurity 3, impurity 4, impurity 5, impurity 6, impurity 7, impurity 8, impurity 9, impurity 10, impurity 11, impurity 12, Impurity 13, Impurity 14, Impurity 5, Impurity 16, and Impurity 17 reference substances were added in appropriate amounts, respectively, dissolved in diluent, and diluted to prepare each impurity positioning solution with a concentration o...

Embodiment 2

[0056] Example 2: Examination of the durability of chromatographic conditions - the pH of the mobile phase A is different

[0057] The only difference between Example 2 and Example 1 is that the pH of the mobile phase A used is different (pH 4.0±0.2).

[0058] The specific chromatographic conditions are as follows:

[0059] Mobile phase A: 0.1% sodium dihydrogen phosphate solution (adjust pH to 4.2 or 3.8 with phosphoric acid)

[0060] Other chromatographic conditions are the same as in Example 1.

[0061] Test results:

[0062] According to the above chromatographic conditions, the system suitability solution was injected, and the results showed that the separation degree of each impurity was good, indicating that the pH of the mobile phase A phase was between 3.8 and 4.2, and other conditions remained unchanged. Impurities are effectively separated.

Embodiment 3

[0063] Example 3: Examination of the durability of chromatographic conditions - different column temperatures

[0064] The only difference between Example 3 and Example 1 is that the column temperature is different (30±5°C).

[0065] The specific chromatographic conditions are as follows:

[0066] Column temperature: 25℃ or 35℃

[0067] Other chromatographic conditions are the same as in Example 1.

[0068] Test results:

[0069] According to the above chromatographic conditions, the system suitability solution was injected, and the separation degree of each impurity was good, indicating that the column temperature was between 25 and 35 °C, and other conditions remained unchanged, and the 17 impurities listed in Table 1 in the system suitability solution could be effectively separated.

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Abstract

The invention provides a method for determining related substances in a glimepiride bulk drug. The method adopts a high performance liquid chromatography (HPLC) method and comprises the following steps: (1) preparing a test solution and a reference solution; (2) carrying out gradient elution by using a 0.1% sodium dihydrogen phosphate solution (the pH value is adjusted to 4.0 by using phosphoric acid) as a mobile phase A and acetonitrile as a mobile phase B; and (3) respectively injecting the test solution and the reference solution. According to the method, 17 impurities in the glimepiride raw material medicine can be effectively separated, and the method has high system applicability and can be used for controlling related substances in the glimepiride raw material medicine.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for determining related substances in a glimepiride bulk drug. Background technique [0002] Glimepiride is a sulfonyl oral hypoglycemic drug, suitable for mild to moderate type 2 diabetes mellitus that cannot be controlled by diet and physical exercise. Glimepiride is a third-generation sulfonylurea hypoglycemic drug developed by Hocchst MarionRoussel (HMR) in Germany. It was first marketed in Sweden under the trade name Amaryl in 1995, and was approved by the FDA to enter the US market in 1996. Market listing; listed in Japan in 2000 and approved in China in the same year. The synthetic route of glimepiride is as follows: [0003] [0004] During the synthesis process, some process impurities and degradation impurities will be generated, such as intermediates and position isomer impurities of glimepiride, intermediates such as methyl and ethyl carbamate impurities, an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/34G01N30/74G01N2030/027G01N2030/042Y02A50/30
Inventor 宋更申安百锋习雪娥黄大卫
Owner BEIJING YUEKANGKECHUANG PHARM TECH CO LTD
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