Determination of amlodipine and furosemide with newly developed and validated rp-hplc method in commercially available tablet dosage forms

Küçük Resim Yok

Tarih

2012

Dergi Başlığı

Dergi ISSN

Cilt Başlığı

Yayıncı

Hacettepe University, Faculty of Pharmacy

Erişim Hakkı

info:eu-repo/semantics/closedAccess

Özet

The aim of this study was to develop a new, fast, reliable and validated RP-HPLC method for the simultaneous determination of amlodipine and furosemide in tablet dosage forms. A C18 column (Fortis™ 250x4.60 mm 5 ?m) which was heated at 45oC during the analysis, was used for the separation and quantification of these drugs. The mobile phase consisted of water (15 mM o-phosphoric acid, pH 5.0) and acetonitrile (50:50 v/v). Analyses were run at a flow rate 1.0 mL.min-1 and UV detector was set at 238 nm. The injection volume was 20 ?L and total run time for an assay was approximately 5 min. The developed method was validated according to the ICH guideline. For the application of the proposed RP-HPLC method, commercially available four different AML containing tablets (one reference (Norvasc) and three generic (Dilapin, Monovasc, Penvasc) tablets) and commercially available two different FSM containing tablets (one reference (Lasix) and one generic (Desal) tablet) were obtained from the market and analyzed for their drug content. Under the given chromatographic conditions, AML and FSM were eluted at 4.28 and 3.68 min., respectively. The method was linear in the concentration range of 1.0 to 16.0 ?g.mL-1 and 0.1 to 12.0 ?g.mL-1 for AML and FSM, respectively with a correlation coefficient >0.999. LOD and LOQ were 0.642 ?g.mL-1 and 2.139 ?g.mL-1 for AML 0.010 ?g.mL-1 and 0.031 ?g.mL-1 for FSM, respectively. Under the conditions used, the analysis completely fulfilled the system suitability test limits suggested by FDA for the quantitative chromatographic methods. The method was successfully applied for the analysis of these drugs in commercially available tablets. © 2012, Hacettepe University, Faculty of Pharmacy. All rights reserved.

Açıklama

Anahtar Kelimeler

Amlodipine, Drug Analysis, Furosemide, HPLC

Kaynak

Hacettepe University Journal of the Faculty of Pharmacy

WoS Q Değeri

Scopus Q Değeri

Q4

Cilt

32

Sayı

2

Künye