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

Result code in 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>
Result on the web
<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>

Result language
angličtina
Original language name
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
Original language description
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
Czech name
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Czech description
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Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
CB - Analytical chemistry, separation
OECD FORD branch
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Project
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Continuities
S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year
2015
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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