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Composition and detection method of related substance in pramipexole starting material

A detection method and a technology for related substances are applied in the field of chemical analysis and detection of pharmaceutical impurities to achieve good system applicability, specificity, and convenient control.

Active Publication Date: 2019-04-09
BRILLIANT PHARMA CHENGDU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] There are impurities from the synthesis process and other sources in the starting material (S)-2,6-diamino-4,5,6,7-tetrahydrobenzothiazole, and its detection and control are used to control the purity of pramipexole It is of great significance, and there is no research and report about the impurities in the starting material in the prior art

Method used

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  • Composition and detection method of related substance in pramipexole starting material
  • Composition and detection method of related substance in pramipexole starting material
  • Composition and detection method of related substance in pramipexole starting material

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0110] Embodiment 1 uses screening result to carry out impurity detection

[0111] Use high performance liquid chromatography analysis method to detect and comprise the quantitative detection of impurity PMH-SM1-Z1, impurity PMH-SM1-Z3 in starting material PMH-SM1, chromatographic conditions are as follows:

[0112] Chromatographic column: the model is Thermo hypersil Gold Aq, 4.6mm×150mm, 5μm.

[0113] Mobile phase: use phosphate buffer (weigh 4.6g sodium octane sulfonate, 9.1g potassium dihydrogen phosphate, add water 1000ml to dissolve, adjust pH value to 3.0 with phosphoric acid) as mobile phase A, use acetonitrile-mobile phase A volume The ratio of 50:50 is liquidity B;

[0114] Detection wavelength: select wavelength 264nm to detect impurity PMH-SM1-Z1 and other unknown impurities, select wavelength 210nm to detect impurity PMH-SM1-Z3.

[0115] Detection column temperature: 40°C.

[0116] (1) Get an appropriate amount of starting material to be detected, accurately we...

Embodiment 2

[0133] Application of embodiment 2 detection method

[0134] Using the chromatographic conditions and detection method of Example 1, the pramipexole starting material (S)-2,6-diamino-4,5,6,7-tetrahydrobenzothiazole was detected for multiple batches of impurities. The results are shown in the table below.

[0135] Table 1. The first batch of test results

[0136]

[0137] Table 2. The second batch of test results

[0138]

[0139] Table 3. The third batch of test results

[0140]

[0141] The above results illustrate that the detection method of the present invention has stability and repeatability, and can stably detect the pramipexole starting materials of different manufacturers and batches.

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Abstract

The invention provides a composition and a detection method of related substance in pramipexole starting material. The composition comprises (S)-2,6-diamine-4,5,6,7-tetrahydrobenzothiazole and impurities; the impurities comprise PMH-SM1-Z1 and / or PMH-SM1-Z3, wherein the content of the (S)-2,6-diamine-4,5,6,7-tetrahydrobenzothiazole is greater than 99%, and the content of the PMH-SM1-Z1 is not morethan 0.5%, and the content of the PMH-SM1-Z3 is not more than 0.1%. The composition can be used as the pramipexole starting material, and the impurity content is clear and controllable. The inventionprovides an accurate and effective detection method for the detection of the related substance in the pramipexole starting material, thereby guaranteeing the product quality of the pramipexole.

Description

technical field [0001] The invention belongs to the field of chemical analysis and detection of drug impurities, in particular to a detection method for impurities in pramipexole starting materials. Background technique [0002] Pramipexole, also known as Mirapa, is a white to off-white crystalline powder chemical, usually in the form of hydrochloride hydrate (dihydrochloride monohydrate). The chemical name is (S)-2-amino-4,5,6,7-tetrahydro-6-propylamine-benzothiazole, the molecular formula is C10H17N3S, and the molecular weight is 211.33. Pramipexole is an antihistamine that is mainly used clinically to treat Parkinson's disease and its syndromes. Can be used alone or in combination with levodopa. [0003] Pramipexole starting material (S)-2,6-diamino-4,5,6,7-tetrahydrobenzothiazole (PMH-SM1), the structural formula is as follows: [0004] [0005] There are impurities from the synthesis process and other sources in the starting material (S)-2,6-diamino-4,5,6,7-tetrah...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 陈翠翠周一帆罗鸣苏忠海
Owner BRILLIANT PHARMA CHENGDU