DOI: 10.21276/ajptr
Sun, 21 Jul 2019

Stability Indicating Analytical Method Development and Validation For Estimation of Donepezil HCL and Itís Pharmaceutical Dosage Form

Rushiraj Devidas  Gaikwad1,  Rajendra  B. Patil1, Snehal B. Ghanwat1

1.Department of Pharmaceutical Quality Assurance JSPM’s Rajarshi Shahu College of  Pharmacy and Research, Tathawade  Pune-33


A simple and sensitive high performance thin layer chromatography (HPTLC) method has been developed for the quantitative estimation of Donepezil HCL in its bulk and tablet dose tablet formulation (5 mg). Donepezil HCL was chromatographed on silica gel 60 F254 TLC plate using  methanol : toluene (2:8, v/v) as mobile phase. Donepezil HCL showed Rf value 0.54 + 0.008 and scanned at 245 nm using a camag TLC scanner 3. The method was validated in terms of linearity (100 – 800 ng/spot), precision (system precision = 0.0123 and method precision = 0.0084), accuracy (100.3 ± 0.76) and specificity. The limit of detection and limit of quantification for Donepezil HCL were found to be 1.72 ng/spot and 2.07 ng/spot, respectively. The developed method was successfully used for the assay of Donepezil HCL tablet formulation. This method also contain forced degradation studies for standard and tablet. The method was found to be simple, sensitive, specific, accurate and precise and can be used for the routine quality control testing of Donepezil HCL in tablet dosage form.

Keywords: Donepezil HCL , HPTLC, tablet, validation, forced degradation studies.

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