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A method for checking related substances in alfacalcidol tablets

An inspection method and technology of related substances, which can be used in instruments, measuring devices, scientific instruments, etc., and can solve problems such as lack of inspection methods

Active Publication Date: 2021-03-30
NANJING HERON PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The object of the present invention is to provide a kind of high performance liquid chromatography analysis method of the related substance of alfacalcidol tablet, to overcome the defect that the related substance inspection method of alfacalcidol tablet lacks in the prior art, better meet Quality Control Requirements for Alfacalcidol Tablets

Method used

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  • A method for checking related substances in alfacalcidol tablets
  • A method for checking related substances in alfacalcidol tablets
  • A method for checking related substances in alfacalcidol tablets

Examples

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Effect test

Embodiment 1

[0075] Example 1: A high-performance liquid chromatography analysis method for related substances in alfacalcidol tablets, the specification of which is 0.5 μg.

[0076] (1) Take 50 tablets of this product, equivalent to 25μg alfacalcidol, put them in a 50ml Nessler colorimetric tube, add 25ml of water, vortex until the tablets are completely disintegrated, add 10ml of ethyl acetate, shake fully, and let Set to separate layers, take the upper layer solution and concentrate it to dryness under reduced pressure, repeat the above process for a total of three times; add 5ml of methanol / water mixture with a volume ratio of 80:20 to the residue after concentration to dryness, mix well, and use a glass syringe to inject 0.45μm The test solution is obtained by filtering with a polytetrafluoroethylene filter membrane; accurately measure 100 μl of the test solution, place it in a 10ml measuring bottle, dilute to the mark with a methanol / water mixture with a volume ratio of 80:20, and sha...

Embodiment 2

[0088] Example 2: A high-performance liquid chromatography analysis method for related substances in alfacalcidol tablets, the specification of which is 0.25 μg.

[0089] (1) Take 50 tablets of this product, equivalent to 25μg alfacalcidol, put them in a 50ml Nessler colorimetric tube, add 25ml of water, vortex until the tablets are completely disintegrated, add 10ml of ethyl acetate, shake fully, and let Set to separate layers, take the upper layer solution and concentrate it to dryness under reduced pressure, repeat the above process for a total of three times; add 2.5ml of methanol / water mixture with a volume ratio of 80:20 to the residue after concentration to dryness, mix well, and inject it through a glass syringe through 0.45 μm polytetrafluoroethylene filter membrane to obtain the test solution; accurately measure 100 μl of the test solution, place it in a 10ml measuring bottle, dilute to the mark with a methanol / water mixture with a volume ratio of 80:20, shake Unifor...

Embodiment 3

[0101] Example 3 High performance liquid chromatography analysis method for related substances in alfacalcidol tablets, the specification of which is 0.5 μg.

[0102] (1) Take 50 tablets of this product, equivalent to 25μg alfacalcidol, put them in a 50ml Nessler colorimetric tube, add 25ml of water, vortex until the tablets are completely disintegrated, add 10ml of ethyl acetate, shake fully, and let Set to separate layers, take the upper layer solution and concentrate it to dryness under reduced pressure, repeat the above process for a total of three times; add 5ml of methanol / water mixture with a volume ratio of 80:20 to the residue after concentration to dryness, mix well, and use a glass syringe to inject 0.45μm The test solution is obtained by filtering with a polytetrafluoroethylene filter membrane; accurately measure 100 μl of the test solution, place it in a 10ml measuring bottle, dilute to the mark with a methanol / water mixture with a volume ratio of 80:20, and shake ...

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Abstract

The invention discloses a high performance liquid chromatography method for alfacalcidol tablet related substances. A sample solution and a control solution are obtained by adopting octadecylsilane bonded silica as a filler and an acetonitrile-water mixed solution as a mobile phase, adopting an ultraviolet detector for a wavelength of 265 nm and especially adopting a vortex-extraction-concentration way, so the detection of an extremely low dose of a drug in the above tablet and related substances thereof is greatly ensured. The method be used to simultaneously analyze all known impurities in the alfacalcidol tablet, and allows the content of each known impurity to be effectively controlled by a main component self-contrasted technology with a correction factor, the resolution among all impurity peaks and the resolution between a main peak and the adjacent impurity peak are respectively greater than 1.5, and the peak purities of the main peak and all the impurity peaks are respectivelymore than 1.0. The high performance liquid chromatography method is a simple and reliable analysis method for the quality control of the alfacalcidol tablet.

Description

technical field [0001] The invention belongs to a method for checking related substances of pharmaceutical preparations, in particular to a method for checking related substances of alfacalcidol tablets. Background technique [0002] The chemical name of alfacalcidol is (5Z,7E)-9,10-cyclocholesta-5,7,10(19)-triene-1α,3β-diol. The structural formula is as follows, [0003] . [0004] Alfacalcidol is rapidly converted in the liver to 1,25-dihydroxyvitamin D3, a metabolite of vitamin D3 that regulates calcium and phosphate metabolism. Because of the rapid conversion process, the clinical effect of alfacalcidol is basically the same as that of 1,25-dihydroxyvitamin D3. Its main function is to increase the level of 1,25-dihydroxyvitamin D3 in the blood circulation in the body, thereby increasing the intestinal absorption of calcium and phosphate, promoting bone mineralization, reducing the level of plasma parathyroid hormone, and hyperthyroidism (with bone disease) patient...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/08G01N30/14G01N30/86G01N30/74
CPCG01N30/02G01N30/06G01N30/08G01N30/14G01N30/74G01N30/8634G01N2030/146
Inventor 芮清清刘婷婷闵涛徐丽曹卫王芳
Owner NANJING HERON PHARM CO LTD
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