HPLC method development for the simultaneous analysis of amlodipine and valsartan in combined dosage forms and in vitro dissolution studies
Küçük Resim Yok
Tarih
2010
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Univ Sao Paulo, Conjunto Quimicas
Erişim Hakkı
info:eu-repo/semantics/openAccess
Özet
A simple, rapid and reproducible HPLC method was developed for the simultaneous determination of amlodipine and valsartan in their combined dosage forms, and for drug dissolution studies. A C 18 column (ODS 2, 10 mu m, 200 x 4.6 mm) and a mobile phase of phosphate buffer (pH 3.6, 0.01 mol L-1): acetonitrile: methanol (46: 44: 10 v/v/v) mixture were used for separation and quantification. Analyses were run at a flow-rate of 1 mL min(-1) and at ambient temperature. The injection volume was 20 mu L and the ultraviolet detector was set at 240 nm. Under these conditions, amlodipine and valsartan were eluted at 7.1 min and 3.4 min, respectively. Total run time was shorter than 9 min. The developed method was validated according to the literature and found to be linear within the range 0.1 -50 mu g mL(-1) for amlodipine, and 0.05 - 50 mu g mL(-1) for valsartan. The developed method was applied successfully for quality control assay of amlodipine and valsartan in their combination drug product and in vitro dissolution studies.
Açıklama
Anahtar Kelimeler
Amlodipine besylate, Valsartan, High Performance Liquid Chromatography, Method Development, Validation, Dissolution Study
Kaynak
Brazilian Journal of Pharmaceutical Sciences
WoS Q Değeri
Q4
Scopus Q Değeri
Q2
Cilt
46
Sayı
4
