STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF MEMANTINE HCl AND DONEPEZIL HCl USING RP-HPLC
Keywords:
Memantine Hydrochloride, Donepezil Hydrochloride, RP-HPLC, UV DetectorAbstract
Objective: To develop and validate stability indicating method for the analysis of Memantine HCl and Donepezil HCl.
Methods: The chromatographic separation was performed on Hypersil BDS (4.6 x 150 mm, 5m) using Sodium dihydrogen ortho phosphate: Acetonitrile (30:70v/v) at a flow rate of 1 ml/min and detection of both the eluents was carried out by UV Detector.
Results: The Retention time of Memantine HCl and Donepezil HCl were found to be 2.833 min. and 4.777 min respectively. Method was found to be linear over the range of 40-120μg/ml for Memantine HCl and 20-60μg/ml for Donepezil HCl. Percentage recovery of Memantine HCl and Donepezil HCl was found to be 99.62% and 99.45% respectively. The percentage purity thus found is 98.5% and 98.6% for Memantine HCl and Donepezil HCl. The Limit of Detection of Memantine HCl and Donepezil HCl is 3.69 mg/ml and 2.72 mg/ml. and Limit of Quantification of Memantine HCl and Donepezil HCl is 11.13 mg/ml and 8.25 mg/ml respectively. In the stress degradation studies, it was found that Memantine HCl and Donepezil HCl showed no degradation in acid (0.1M HCl), base (0.1M NaOH), peroxide, heat and sunlight.
Conclusion: A new sensitive, simple, and stability indicating high performance layer chromatographic (HPLC) method has been developed and validated for determination of Memantine HCl and Donepezil HCl. The proposed method can be used for routine determination of Memantine HCl and Donepezil HCl stability.
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