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Analysis method of related substances in Ebastine

A technology related to substances and analysis methods, applied in the field of drug analysis, can solve the problems of long analysis time period, complicated mobile phase configuration, inconvenient measurement, etc., and achieve reliable measurement results

Active Publication Date: 2014-04-02
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing high performance liquid chromatography analysis method for related substances of ebastine (6th edition of the European Pharmacopoeia) is very inconvenient to measure, the analysis time period is too long, exceeding 2 hours, and the mobile phase configuration is complicated

Method used

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  • Analysis method of related substances in Ebastine
  • Analysis method of related substances in Ebastine
  • Analysis method of related substances in Ebastine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1 Determination of Related Substances of Ebastine—Measurement of European Pharmacopoeia (EP6 Edition)

[0041] Chromatographic conditions:

[0042] Chromatographic column: Agilent SB-CN 4.6×150mm 5μm, detection wavelength: 210nm

[0043] Mobile phase: acetonitrile:phosphoric acid (1.1g / L adjust pH value=5.0 with 40g / L sodium hydroxide solution)=35:65

[0044] Need testing solution preparation: take by weighing about 125.0 mg of need testing, accurately weigh, put in 50ml measuring bottle, add mixed solution [acetonitrile: phosphoric acid (1.1g / L adjust pH value=5.0 with 40g / L sodium hydroxide solution) )=65:35] dissolve and dilute to the mark, shake well, filter, and obtain. (2.5mg / ml)

[0045] see attached results figure 1 , as can be seen from the chromatogram, the retention time of ebastine is 120min, according to the chromatographic collection time requirement (1.4 times of the retention time of ebastine), the whole collection time needs 170min, about 3 ...

Embodiment 2

[0046] Embodiment 2 Determination of related substances of ebastine (1)

[0047] Chromatographic conditions: detection wavelength: 250nm, 210nm, mobile phase: A: acetonitrile B: 0.3% triethylamine solution (phosphoric acid to adjust pH value = 6.5), flow rate: 1.2ml / min; gradient elution:

[0048] time (minutes)

A(％)

B(％)

0

48

52

9

67

33

16

75

25

50

75

25

50.01

48

52

[0049] Preparation of the test solution: Weigh the appropriate amount of each impurity reference substance and ebastine sample, weigh them accurately, add acetonitrile to gradually dilute to the appropriate solubility, shake well, and filter to obtain. Inject the sample and record the chromatogram.

[0050] See the results: Attached figure 2 (detection wavelength 250nm), attached image 3 (Detection wavelength 210nm).

Embodiment 3

[0051] Embodiment 3 Determination of related substances of ebastine (two)

[0052] Chromatographic conditions: detection wavelength: 250nm, mobile phase: A: methanol, B: 0.3% triethylamine solution (phosphoric acid to adjust the pH value = 6.8), flow rate: 1.2ml / min, gradient elution:

[0053] time (minutes)

[0054] Preparation of the test solution: Weigh the appropriate amount of each impurity reference substance and ebastine sample respectively, accurately weigh them, add methanol to gradually dilute to a suitable solubility, shake well, and filter to obtain. Inject the sample and record the chromatogram. see attached results Figure 4 (the organic phase in the mobile phase is methanol).

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Abstract

The invention relates to an analysis method of related substances in Ebastine. Using reversed-phase high performance liquid chromatography selecting octadecylsilane bonded silica as a packing material, selecting a proper organic phase and a buffer solution as the mobile phase, and adopting gradient elution, the method can effectively separate the related substances in the pharmaceutical material Ebastine. The method is quick, simple, effective and reliable.

Description

Technical field: [0001] The invention relates to a drug analysis method, in particular to a method for determining related substances of ebastine by high performance liquid chromatography. Background technique: [0002] The so-called "related substances" in drug analysis refer to substances that are not the main components in a specific drug, but are related to the ingredients. Because a drug has to go through a relatively complicated and lengthy process from the synthesis of raw materials to the preparation of related preparations, storage, transportation, and use, during this period, each process may produce related substances, such as production. Starting materials, reagents, intermediates, by-products and isomers may be brought in; during storage and transportation, special impurities such as degradation products, polymers or crystal transformations may be produced. In order to ensure the safety and effectiveness of the drug, the actual production situation must also be...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/36G01N30/06
Inventor 肖玲孙小路
Owner CHONGQING HUAPONT PHARMA
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