Development and Validation of Stability Indicating HPTLC Method for Determination of Donepezil Hydrochloride and its related substances in Bulk Drug and Pharmaceutical Dosage Form

Abstract

Context: A new, simple, selective, and affordable HPTLC technique for the analysis of donepezil hydrochloride (DH) and its associated compounds was developed and verified in accordance with ICH guidelines. Method: Donepezil Hydrochloride and Related Substances were densitometrically analyzed in the absorbance mode at 320 nm. The stationary phase was 60 F—254 silica gel pre-coated on aluminium TLC plates. Butanol, water, and glacial acetic acid were the components of the mobile phase (4:5:1, v/v/v). Result: It was discovered that this method provides compact places for DH (RF 0.53± 0.03) .Testing for stability indicators (force degradation) was done in acidic and alkaline conditions, as well as with dry heat and photodegradation. The degradation products were clearly distinguished from the pure drug by their markedly differing RF values. For Validation of method linearity, precision, robustness, limit of detection (LOD), limit of quantification (LOQ), ruggedness, and accuracy parameters are verified. LOD and LOQ were found to be 80.85 and 245 ng per spot, respectively, and linearity was found in the range 400-1200 ng per spot with a considerably high value of the correlation coefficient r2 = 0.999 is found. A 0.43% coefficient of variance is discovered. Conclusion: The approach was repeatable and specific for estimating donepezil hydrochloride and related compounds, according to statistical analysis Donepezil Hydrochloride can be quantified even when there are degraded products and related compounds present. It is commercially available for the estimation of related compounds and Donepezil hydrochloride.