Simple high-performance liquid chromatographic method for determination of donepezil hcl in pharmaceutical formulations


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Bulduk İ., Aydın B. S.

Journal of Chemical Metrology, cilt.14, sa.1, ss.69-76, 2020 (ESCI, Scopus, TRDizin) identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 14 Sayı: 1
  • Basım Tarihi: 2020
  • Doi Numarası: 10.25135/jcm.41.20.04.1622
  • Dergi Adı: Journal of Chemical Metrology
  • Derginin Tarandığı İndeksler: Emerging Sources Citation Index (ESCI), Scopus, TR DİZİN (ULAKBİM)
  • Sayfa Sayıları: ss.69-76
  • Anahtar Kelimeler: Donepezil HCl, HPLC-UV, Measurement uncertainty, Method validation, Pharmaceuticals
  • Açık Arşiv Koleksiyonu: AVESİS Açık Erişim Koleksiyonu
  • Uşak Üniversitesi Adresli: Evet

Özet

Donepezil HCl is a hydrochloride salt of a piperidine derivative acetylcholinesterase inhibitor and, it uses in treatment demantia of Alzheimer’s disease. In this study, a sensitive and rapid HPLC-UV method was developed and validated for determination of Donepezil HCl in API and tablet dosage forms. Chromatographic separation was performed using a Ace 5 C18 (5 μm, 250 x 4.6 mm) by using isocratic phosphate buffer at pH:2.0 and acetonitrile (55:45, v/v) mobile phase was used at the rate of 1.2 mL/min. The column temperature was set at 30°C and the UV detection was recorded at 268 nm. The method was validated with respect to specificity, precision, accuracy, linearity, repeatability and reproducibility parameters in a concentration range of 25-125 µg/mL. The limit of detection (LOD) and limit of quantification (LOQ) were determined as 1.40 and4.20 µg/mL, respectively. The uncertainty budget of the measurement for Donepezil HCl was estiamted as 5.80 % at 95% confidence level (k = 2).