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Analysis method for determining content of main drug in pramipexole dihydrochloride sustained-release tablets

A technology for pramipexole hydrochloride and pramipexole, which is applied in the analysis field of determining the content of main drugs in pramipexole hydrochloride sustained-release tablets, can solve the problems of complicated steps, loss of test samples, and low product detection content, and achieves decomposition Short time, fully extracted effect

Pending Publication Date: 2020-09-29
QILU PHARMA HAINAN +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Mobile phase is: acetonitrile: buffer solution (get 1.0ml trifluoroacetic acid and 0.5ml triethylamine and add water and dilute to 1000ml) (5:95) is mobile phase, although this method can measure the content of pramipexole hydrochloride, but slow The components of excipients in release tablets are different. In addition, in the process of processing the test product, it is necessary to grind the test product first, and then add methanol for ultrasonic dissolution. The steps are complicated, and it may cause the test product to Loss of test samples, resulting in low detection content of products

Method used

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  • Analysis method for determining content of main drug in pramipexole dihydrochloride sustained-release tablets
  • Analysis method for determining content of main drug in pramipexole dihydrochloride sustained-release tablets
  • Analysis method for determining content of main drug in pramipexole dihydrochloride sustained-release tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1 System suitability / system precision

[0039] (1) Solution preparation

[0040] Diluent a: methanol-acetonitrile-hydrochloric acid (670:330:1), the preparation method is as follows: at room temperature, measure 670ml of methanol and 330ml of acetonitrile respectively, put them in the same reagent bottle with stopper, and then add 1ml into the bottle Hydrochloric acid, mix well and serve.

[0041]Diluent b: phosphate buffer (pH3.0), the preparation method is as follows: take 6.8g of potassium dihydrogen phosphate, add appropriate amount of water to dissolve and dilute to 1000ml, adjust the pH value to 3.0 with phosphoric acid.

[0042] Content reference substance solution: Take pramipexole hydrochloride reference substance 7.874mg, accurately weigh it, put it in a 50ml volumetric flask, add diluent a to dissolve and dilute to the mark, shake well, and use it as the reference substance stock solution. Accurately measure 1ml, put it in a 100ml volumetric flas...

Embodiment 2

[0056] Example 2 Specificity

[0057] (1) Solution preparation

[0058] Diluent a: with embodiment 1.

[0059] Diluent b: with embodiment 1.

[0060] Blank excipient solution: take 250.372 mg of blank excipient that has been mixed uniformly (weighed by the weight ratio of the excipient in the smallest size tablet, that is, 0.375 specification) and place it in a 25ml volumetric flask, add an appropriate amount of diluent a, ultrasonically for 10 minutes and Shake, let cool to room temperature, dilute to the mark with diluent a, shake well, centrifuge at 10,000 rpm for 10 minutes, accurately measure 2ml of the supernatant, put it in a 20ml volumetric flask, dilute to the mark with diluent b, Shake well.

[0061] Impurity A positioning solution: the same as the impurity A stock solution in Example 1. Precisely measure 1ml of impurity A stock solution, put it in a 100ml volumetric flask, add diluent b to dilute to the mark, shake well, and use it as impurity A positioning solu...

Embodiment 3

[0071] Example 3 Linearity and Range

[0072] (1) Solution preparation

[0073] Diluent a: with embodiment 1.

[0074] Diluent b: with embodiment 1.

[0075] Linear stock solution: take 7.874mg of pramipexole hydrochloride reference substance, weigh it accurately, put it in a 50ml volumetric flask, dissolve it with diluent a and dilute to the mark, and shake well.

[0076] 50% linear solution: Accurately measure 1ml of linear stock solution, put it in a 200ml volumetric flask, dilute to the mark with diluent b, and shake well.

[0077] 80% linear solution: Accurately measure 2ml of linear stock solution, put it in a 250ml volumetric flask, dilute to the mark with diluent b, and shake well.

[0078] 100% linear solution: Accurately measure 1ml of linear stock solution, put it in a 100ml volumetric flask, dilute to the mark with diluent b, and shake well.

[0079] 120% linear solution: Accurately measure 3ml of linear stock solution, put it in a 250ml volumetric flask, dilut...

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Abstract

The invention discloses a method for determining a content of pramipexole in pramipexole dihydrochloride sustained-release tablets by adopting high performance liquid chromatography, and belongs to the technical field of pharmaceutical analysis. The method comprises the following steps: dissolving a test sample by adopting two diluents, taking octadecylsilane chemically bonded silica as a chromatographic column, and taking a buffer solution formed by potassium dihydrogen phosphate and sodium octanesulfonate; and taking acetonitrile as a mobile phase to determine the content. Methodology verifies that the method can effectively determine the content of the test sample, and the method can completely extract the main drug in the sustained release tablets, and is simple to operate.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and specifically discloses an analysis method for determining the content of a main drug in pramipexole hydrochloride sustained-release tablets. The method can effectively extract and detect the content of pramipexole in sustained-release tablets, and can be used as an important part of the quality control of pramipexole hydrochloride sustained-release tablets. Background technique [0002] Pramipexole hydrochloride is a complete non-ergot alkaloid dopamine receptor agonist, and its aminobenzothiazole structure can selectively act on the D2 receptor subfamily. Pramipexole attenuates dyskinesia in Parkinson's patients by stimulating striatal dopamine receptors. [0003] The chemical name of pramipexole hydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-propylamine-benzothiazole monohydrate dihydrochloride, and the molecular formula is C 10 h 17 N 3 S 2HCl H 2 O, with a relative molecular...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 宋丽孙艳艳单衍强李宏贞王全亮
Owner QILU PHARMA HAINAN
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