A new, rapid, stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11310%2F15%3A10311989" target="_blank" >RIV/00216208:11310/15:10311989 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1016/j.jpba.2015.01.059" target="_blank" >http://dx.doi.org/10.1016/j.jpba.2015.01.059</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.jpba.2015.01.059" target="_blank" >10.1016/j.jpba.2015.01.059</a>

Jazyk výsledku

angličtina

Název v původním jazyce

A new, rapid, stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form

Popis výsledku v původním jazyce

A new rapid stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form was developed. The separation of Ph. Eur. related substances of amlodipine besylate (A, B, D, E, F, G), hydrochlorothiazide (A, B, C), valsartan (B, C), two other valsartan impurities (S)-2-(N-{[2'-cyanobiphenyl-4-yl]methyl}pentanamido)-3-methylbutanoic acid and (S)-3-methyl-2-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methylamino}butanoic acid and several unknown impurities was achieved by reversed phase liquid chromatography with UV detection. The detection wavelengths were set as follows: 225 nm for valsartan, its impurities and for the impurity D of amlodipine, 271 nm for hydrochlorothiazide and its impurities and 360 nm for amlodipine and its impurities except for impurity D. Zorbax Eclipse C8 RRHD (100 mm x 3.0 mm, 1.8 mu m) was used as a separation column and the analytes were eluted within 11 min by

Název v anglickém jazyce

A new, rapid, stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form

Popis výsledku anglicky

A new rapid stability-indicating UPLC method for separation and determination of impurities in amlodipine besylate, valsartan and hydrochlorothiazide in their combined tablet dosage form was developed. The separation of Ph. Eur. related substances of amlodipine besylate (A, B, D, E, F, G), hydrochlorothiazide (A, B, C), valsartan (B, C), two other valsartan impurities (S)-2-(N-{[2'-cyanobiphenyl-4-yl]methyl}pentanamido)-3-methylbutanoic acid and (S)-3-methyl-2-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methylamino}butanoic acid and several unknown impurities was achieved by reversed phase liquid chromatography with UV detection. The detection wavelengths were set as follows: 225 nm for valsartan, its impurities and for the impurity D of amlodipine, 271 nm for hydrochlorothiazide and its impurities and 360 nm for amlodipine and its impurities except for impurity D. Zorbax Eclipse C8 RRHD (100 mm x 3.0 mm, 1.8 mu m) was used as a separation column and the analytes were eluted within 11 min by

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

CB - Analytická chemie, separace

OECD FORD obor

—

Projekt

—

Návaznosti

S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2015

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of Pharmaceutical and Biomedical Analysis

ISSN

0731-7085

e-ISSN

—

Svazek periodika

109

Číslo periodika v rámci svazku

May

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

9

Strana od-do

36-44

Kód UT WoS článku

000353078700005

EID výsledku v databázi Scopus

2-s2.0-84924268789