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Content determination method for sacubitri valsartan trisodium hemi-pentahydrate capsule effective ingredients

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

Active Publication Date: 2018-03-06
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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  • Content determination method for sacubitri valsartan trisodium hemi-pentahydrate capsule effective ingredients
  • Content determination method for sacubitri valsartan trisodium hemi-pentahydrate capsule effective ingredients
  • Content determination method for sacubitri valsartan trisodium hemi-pentahydrate capsule effective ingredients

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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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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 王立强李伟
Owner HUAQIAO UNIVERSITY
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