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A method for determining the content of active ingredients in sacubitril, valsartan trisodium hemipentahydrate capsules

A technology of pentahydrate and active ingredients, which is applied in the field of content determination of active ingredients of sacubitril, trisodium hemi-pentahydrate capsules, and can solve problems such as detection

Active Publication Date: 2020-02-07
HUAQIAO UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The present invention provides a convenient, accurate, efficient and cheap detection method in order to solve the problem of detecting the active ingredient content of sacubitril valsartan trisodium hemipentahydrate before delivery or use

Method used

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  • A method for determining the content of active ingredients in sacubitril, valsartan trisodium hemipentahydrate capsules
  • A method for determining the content of active ingredients in sacubitril, valsartan trisodium hemipentahydrate capsules
  • A method for determining the content of active ingredients in sacubitril, valsartan trisodium hemipentahydrate capsules

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Embodiment 1

[0069] A method for determining the content of active ingredients of sacubitril valsartan trisodium hemipentahydrate capsules, comprising the steps of:

[0070] (1) Preparation of reference substance: Accurately weigh an appropriate amount of sacubitril-valsartan trisodium hemipentahydrate reference substance, add methanol to make a drug containing 50 μg of sacubitril-valsartan trisodium hemipentahydrate per 1 ml solution;

[0071] (2) Preparation of the test product: Take 20 capsules of sacubitril-valsartan trisodium hemipentahydrate from different batches, put them in a mortar and grind them finely through a No. 4 sieve, and take sacubitril-valsartan trisodium An appropriate amount of the content of the semi-pentahydrate capsule sample (approximately equivalent to 10 mg of sacubitril-valsartan trisodium hemi-pentahydrate), accurately weighed, placed in a 20mL volumetric flask, added methanol and shaken to dissolve, filtered, and the filtrate was placed Cool to room temperat...

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Abstract

The invention discloses a content determination method for sacubitri valsartan trisodium hemi-pentahydrate capsule effective ingredients. The content determination method comprises the following steps: firstly taking an appropriate amount of a sacubitri valsartan trisodium hemi-pentahydrate reference substance to prepare the sacubitri valsartan trisodium hemi-pentahydrate reference substance withthe concentration of 50 micrograms per mL, and taking a sacubitri valsartan trisodium hemi-pentahydrate capsule sample to prepare a sacubitri valsartan trisodium hemi-pentahydrate sample for test withthe concentration of 50 micrograms per mL; then establishing the following chromatographic conditions of a high performance liquid: a C18 chromatographic column (4.6 mm * 250 mm, 5 microns), the moving phase is 0.2% diisopropyl amine water solution-N-methyl pyrrolidone, the detection wavelength is 250 nm, the flow velocity is 0.8 mL / min, the column temperature is 30 DEG C, and the sample size is10 microliters; finally accurately absorbing the reference substance and the sample solution for test into a liquid chromatograph for determination respectively. According to the content determinationmethod for sacubitri valsartan trisodium hemi-pentahydrate capsule effective ingredient disclosed by the invention, the determination method is convenient, accurate and reliable, and the quality of the product can be really reflected.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method for determining the content of active ingredients in sacubitril-valsartan trisodium hemipentahydrate capsules. Background technique [0002] Sacubitril and Valsartan Trisodium Hemipentahydrate (Sacubitril and Valsartan Trisodium Hemipentahydrate) is trisodium (4-{[(1S,3R)-1-([1,1'-biphenyl]-4-methylene base)-4-ethoxy-3-methyl-4-oxobutyl]amino}-4-oxobutanoic acid)(N-pentanoyl-N-{[2'-(1H-tetrazolium -5-yl)[1,1'-biphenyl]-4-yl]methyl}-L-valine) hemipentahydrate, molecular weight is 1916.018g / mol, structural formula is as follows: [0003] [0004] Sacubitril valsartan trisodium hemipentahydrate consists of neprilysin inhibitor Sacubitril (NEP inhibitor)-Sacubitril and angiotensin Ⅱ receptor blocker (Angiotensin Ⅱ receptor blocker)-Valsartan valsartan 1:1 equimolecular molar ratio composition, is an orally bioeffective, dual-action angiotensin receptor-neprilysin inhibitor (angi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 王立强李伟
Owner HUAQIAO UNIVERSITY
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