Bio-analytical Method for the Pre-clinical Estimation of Donepezil Hydrochloride in Rabbit Plasma by RP-HPLC

Author:

Surya Anusha Venna R1,RVS Chaitanya Koppala2,Aleti Rajeswari1,Ramana Murthy Kolapalli Venkata1

Affiliation:

1. AU College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India, 530003.

2. Department of Pharmacology, Vignan Institute of Pharmaceutical Technology, Kapujaggrajupeta, Duvvada, Visakhapatnam, India, 530049.

Abstract

A simple, reliable and sensitive RP-HPLC bioanalytical method with PDA as detector was developed for the estimation of donepezil HCl in the rabbit plasma and validated. The biological samples were extracted and analysed using loratadine as internal standard. The sample analysed with Inertsil ODS 150mm x 4.6mm, 5.0µm particle size column using 70:30 v/v of 0.1% trifluoroacetic acid and acetonitrile mobile phase at flow rate of 1mL/min. All the parameters validated were within the limits proposed in bioanalytical method validation guidelines. The linearity was observed in the range of 5-200ng/mL with LOD of 0.9ng/mL. The method was observed to have short analysis time of 6 min and also found to be successful in studying the pharmacokinetic parameters of donepezil HCl.

Publisher

A and V Publications

Subject

Pharmacology (medical),Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference24 articles.

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3. Rogers SL and Friedhoff LT. The efficacy and safety of donepezil in patients with Alzheimer’s disease: results of a US multicentre, randomized, double-blind, placebo-controlled trial. The Donepezil Study Group. Dementia, 1996; 7: 293-303.

4. Burt T. Donepezil and related cholinesterase inhibitors as mood and behavioral controlling agents. Current psychiatry reports. 2000; 2: 473-478.

5. US Pharmacopeia and National Formulary. United States Pharmacopeial Convention, Inc.; 2006. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020690Orig1s000rev.pdf.

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