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High performance liquid chromatographic analysis method of bendamustine hydrochloride and its related substances

A technology of bendamustine hydrochloride and high performance liquid chromatography, which is applied in the detection field of antitumor drug bendamustine hydrochloride and related substances, can solve the problems such as no detailed reports and no standards, and achieves analytical results. The effect of short time period, effective method and simple operation

Active Publication Date: 2012-03-14
CHONGQING HUABANGSHENGKAI PHARM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For the determination method of its related substances and content, not only there is no specific standard, but also there is no detailed report in domestic and foreign literature, and there is no relevant information in the national patent database

Method used

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  • High performance liquid chromatographic analysis method of bendamustine hydrochloride and its related substances
  • High performance liquid chromatographic analysis method of bendamustine hydrochloride and its related substances
  • High performance liquid chromatographic analysis method of bendamustine hydrochloride and its related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Embodiment 1: Determination of related substances of bendamustine hydrochloride (1)

[0050] 1) Determination of related substances of bendamustine hydrochloride - system specificity experiment

[0051] Chromatographic conditions: mobile phase: A: acetonitrile; B: 0.02mol / l potassium hexafluorophosphate solution (phosphoric acid to adjust the pH value to 3.0); A: B = 425: 575 (V: V)

[0052] Preparation of sample solution: Weigh the appropriate amount of each impurity standard (A~H) and finished product, weigh them accurately, put them in the same measuring bottle, add diluent to the appropriate concentration, shake well, and filter to get ready. Inject the sample and record the chromatogram.

[0053] Experimental results: see attached figure 1 , the retention time of the main peak is 12.3min, the separation effect of the main peak and each impurity peak is good, and each impurity peak can be baseline-separated.

[0054] 2) Quantitation limit and detection limit dete...

Embodiment 2～9

[0066] Embodiments 2-9: Determination of Related Substances of Bendamustine Hydrochloride (2-9)

[0067] Mobile phase: A: acetonitrile; B: 0.02mol / l potassium hexafluorophosphate solution (phosphoric acid to adjust the pH value);

[0068]

[0069] Sample solution preparation: Weigh an appropriate amount of the finished product, weigh it accurately, put it in the same measuring bottle, add mobile phase to the appropriate concentration, shake well, and you get it. Inject the sample and record the chromatogram.

[0070] Experimental results: attached Figure 3-10 , each impurity peak is well separated from the main peak, and each impurity peak (unknown impurity 1-4) can be baseline-separated.

Embodiment 10～13

[0071] Embodiments 10-13: Determination of Related Substances of Bendamustine Hydrochloride (10-13)

[0072] Instrument: Agilent 1200 high performance liquid chromatography (DAD detector)

[0073] Mobile phase: A: acetonitrile; B: 0.02mol / l potassium hexafluorophosphate solution (phosphoric acid to adjust the pH value);

[0074]

[0075] Sample solution preparation: Weigh an appropriate amount of the finished product, weigh it accurately, put it in the same measuring bottle, add mobile phase to the appropriate concentration, shake well, and you get it. Inject the sample and record the chromatogram.

[0076] Experimental results:

[0077] 1) by attached Figure 11 , the extracted ultraviolet spectrum shows that each impurity is the homologue of the finished product, and the maximum ultraviolet absorption wavelength is the same. When the detection wavelengths are 220nm, 233nm and 245nm respectively, the levels of impurities are basically the same.

[0078] 2) by attached...

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Abstract

The invention relates to a method for determining related substances of bendamustine hydrochloride through high performance liquid chromatography. In the method, a sample to be detected is prepared into a sample solution with a mobile phase, and then reversed isocratic elution is carried out on an octadecylsilane bonded silica gel chromatographic column, with an organic solvent and a buffer solution as the mobile phase. The method of the invention effectively solves the problems in separation of related substances from bendamustine hydrochloride bulk drugs and detection thereof. The method provided in the invention has the advantages of simplicity, feasibility, and short analysis time cycle.

Description

technical field [0001] The invention relates to a detection method for antineoplastic drug bendamustine hydrochloride and its related substances, in particular to a method for analysis by high performance liquid chromatography. Background technique [0002] In drug analysis, the detection of related substances is an important index to control the quality of drugs. [0003] 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. A drug has to go through a relatively complicated and long 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 starting materials, reagents, intermediates, by-products and isomers, etc. may be brought into production; during storage and transportation, degradation products, Specific impurities such as polym...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/28
Inventor 唐舒棠孙小路
Owner CHONGQING HUABANGSHENGKAI PHARM
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