First order derivative spectrophotometric method for the determination of benidipine hydrochloride pharmaceutical preparations and forced degradation study
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Dosyalar
Tarih
2015
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Pleiades Publishing Inc
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
A simple and rapid first order derivative spectrophotometric method was developed for the determination of benidipine hydrochloride in pure form and pharmaceutical preparations. For the first derivative spectrophotometric method, the distances between two extremum values l (peak-to-peak amplitudes), 230.2/241.5 nm. The proposed method was validated according to the ICH guidelines with respect to linearity, limit of detection, limit of quantification, accuracy, precision (intra- and inter-day) and recovery were evaluated. The linearity of the method was in the range of 0.2-2.0 mu g/mL. Limits of detection and quantification were 0.58 and 1.73 mu g/mL, respectively. The proposed method was successfully applied to the analysis of pharmaceutical preparations. In addition, forced degradation studies were performed on the benidipine hydrochloride drag substance. The drug substance was exposed to the stress conditions of hydrolysis (acid and base).
Açıklama
Anahtar Kelimeler
Human Plasma
Kaynak
Optics and Spectroscopy
WoS Q Değeri
Q4
Scopus Q Değeri
Q4
Cilt
118
Sayı
6