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

Journal of Pharmaceutical and Biomedical Analysis
Jiří VojtaLucie Janečková

Abstract

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: 225nm for valsartan, its impurities and for the impurity D of amlodipine, 271nm for hydrochlorothiazide and its impurities and 360nm for amlodipine and its impurities except for impurity D. Zorbax Eclipse C8 RRHD (100mm×3.0mm, 1.8μm) was used as a separation column and the analytes were eluted within 11min by a programmed gradient mixture of 0.01M phosphate buffer pH 2.5 and acetonitrile. The method was successfully validated in accordance to the International Conference of Harmonization (ICH) guidelines for amlodipine besylate and its impurity D, valsartan and i...Continue Reading

References

Jan 16, 2007·Advanced Drug Delivery Reviews·Satinder Sut Ahuja
Dec 18, 2007·Journal of Pharmaceutical and Biomedical Analysis·Sándor Görög
Apr 5, 2012·Acta Pharmaceutica : a Quarterly Journal of Croatian Pharmaceutical Society and Slovenian Pharmaceutical Society, Dealing with All Branches of Pharmacy and Allied Sciences·Ritesh N Sharma, Shyam Sunder Pancholi
Dec 4, 2012·Indian Journal of Pharmaceutical Sciences·Varsha R GalandeM H Dehghan
Apr 23, 2013·Lancet·Annemijn M Algra
Aug 19, 2014·Acta Informatica Medica : AIM : Journal of the Society for Medical Informatics of Bosnia & Herzegovina : časopis Društva Za Medicinsku Informatiku BiH

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Citations

Oct 30, 2016·Toxicology Mechanisms and Methods·Esra EmerceOmur Bostanci
May 22, 2019·Critical Reviews in Analytical Chemistry·Madhav ShelkeSanjay Sharma
Jun 9, 2020·Critical Reviews in Analytical Chemistry·K S KokilambigaiA Sai Susmitha

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