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Method used for detecting cinacalcet hydrochloride isomerides via HPLC method

A technology of cinacalcet hydrochloride and isomers, which is applied in the field of medicine, can solve the problems affecting the detection of cinacalcet hydrochloride content and no analytical method, and achieve the effect of improving product quality and safety and optimizing process

Active Publication Date: 2017-05-03
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Because the existence of isomer A and isomer B will affect the detection of cinacalcet hydrochloride content, there is no effective analysis method at present, and the establishment of this method makes up for this vacancy

Method used

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  • Method used for detecting cinacalcet hydrochloride isomerides via HPLC method
  • Method used for detecting cinacalcet hydrochloride isomerides via HPLC method
  • Method used for detecting cinacalcet hydrochloride isomerides via HPLC method

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Experimental program
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Effect test

Embodiment 1

[0033] (1) Experimental materials and experimental conditions:

[0034] Chromatographic column: Phenomenex Lux 5u Cellulose-3 column (250mm×4.6mm, 5um), mobile phase: acetonitrile and 0.01mol / L anhydrous sodium dihydrogen phosphate aqueous solution, flow rate: 1ml / min, column temperature: 30°C, detection Wavelength: 222nm, injection volume: 10 μL; use mobile phase for gradient elution, and its gradient elution volume is shown in Table 2.

[0035] (2) Experimental steps:

[0036] Take isomer A, dissolve and dilute it with methanol, and make test solution A containing about 5.0 mg of isomer A per 1 ml of solution;

[0037] Extract 10 μL of test solution A, inject it into the chromatograph, record the chromatogram, see figure 1 .

[0038] (3) Analysis of experimental results

[0039] figure 1 Among them, cinacalcet isomer A has a chromatographic peak with a retention time of about 20.9 min.

Embodiment 2

[0041] (1) Experimental materials and experimental conditions:

[0042] Chromatographic column: Phenomenex Lux 5u Cellulose-3 column (250mm×4.6mm, 5um), mobile phase: acetonitrile and 0.01mol / L anhydrous sodium dihydrogen phosphate aqueous solution, flow rate: 1ml / min, column temperature: 30°C, detection Wavelength: 222nm, injection volume: 10 μL; use mobile phase for gradient elution, and its gradient elution volume is shown in Table 2.

[0043] (2) Experimental steps:

[0044] Take isomer B, dissolve and dilute it with methanol, and prepare test solution B containing about 5.0 mg of isomer B in 1 ml of solution;

[0045] Extract 10 μL of the test solution B, inject it into the chromatograph, record the chromatogram, see figure 2 .

[0046] (3) Analysis of experimental results

[0047] figure 2 Among them, cinacalcet isomer B has a chromatographic peak with a retention time of about 30.4 min.

Embodiment 3

[0049] (1) Experimental materials and experimental conditions:

[0050] Chromatographic column: Phenomenex Lux 5u Cellulose-3 column (250mm×4.6mm, 5um), mobile phase: acetonitrile and 0.01mol / L anhydrous sodium dihydrogen phosphate aqueous solution, flow rate: 1ml / min, column temperature: 30°C, detection Wavelength: 222nm, injection volume: 10 μL; use mobile phase for gradient elution, and its gradient elution volume is shown in Table 2.

[0051] (2) Experimental steps:

[0052] Take cinacalcet hydrochloride (excluding isomers), dissolve and dilute it with methanol, and prepare a test solution C containing about 5.0 mg of cinacalcet hydrochloride in every 1 ml of solution;

[0053] Extract 10 μL of the test solution C, inject it into the chromatograph, record the chromatogram, see image 3 .

[0054] (3) Analysis of experimental results

[0055] image 3 Among them, cinacalcet hydrochloride has a chromatographic peak with a retention time of about 22.3 minutes.

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Abstract

The invention relates to a method used for detecting cinacalcet hydrochloride isomerides via HPLC method, and belongs to the technical field of medicine. According to the method, HPLC method is adopted for detection of cinacalcet hydrochloride isomerides, and chromatographic conditions are defined as following: the adopted chromatographic column is Phenomenex Lux 5<mu> Cellulose-3 column (250mm*4.6mm, 5<mu>m), the adopted mobile phase is acetonitrile and a 0.01mol / L buffered saline solution, flow velocity is controlled to be 0.8 to 1.2ml / min, column temperature is controlled to be 25 to 35 DEG C, detection wave length is controlled to be 222nm, sample amount is controlled to be 10<mu>L. High performance liquid chromatography is adopted to detect two isomerides of cinacalcet hydrochloride in a synthesis finished product, accurate control on the quality of cinacalcet hydrochloride is realized, and it is beneficial for optimizing of technology, and increasing of product quality and safety.

Description

technical field [0001] The invention relates to a method for detecting isomers of cinacalcet hydrochloride by using an HPLC method, and belongs to the technical field of medicine. Background technique [0002] Cinacalcet hydrochloride is a calcimimetic agent developed by U.S. NPS Pharmaceuticals. On March 8, 2004, FDA approved the production of cinacalcet hydrochloride produced by Amgen (the licensee of the product of NPS Pharmaceuticals). It is Sensipar; In October 2007, cinacalcet hydrochloride produced by Kylin Pharmaceutical Co., Ltd. was listed in Japan under the trade name REGPARA, and the specifications were 25mg and 75mg (calculated as cinacalcet). Cinacalcet is the first drug in a new class of compounds known as calcimimetics, which activate calcium receptors in the parathyroid glands, thereby reducing parathyroid hormone (PTH) secretion. It modulates the behavior of the parathyroid calcium receptor, reducing the levels of parathyroid hormone, calcium, phosphorus, ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 姜明冯新光
Owner HUAREN PHARMACEUTICAL CO LTD
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