Friday , 29 March 2024

RP- HPLC Method Development and Validation for the Simultaneous Estimation of Donepezil and Memantine

S. Uday Venkata Sai Kumar*, G. Dharma Moorthy1, N. Sujani2, S. Veera Sekhar3, E. Vijay Kumar4
*Krishna Teja Pharmacy College, Tirupati, A.P., India
1Associate Professor, Krishna Teja Pharmacy College, Tirupati, A.P., India
2,3,4 Assistant Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India

A  B  S  T  R A C T
A new method was established for the simultaneous estimation of donepezil and memantine by RP-HPLC method.  The chromatographic conditions were successfully developed for th1e separation of donepezil and memantine by using Xterra C18 5µm (4.6*250mm) column, flow rate was 1ml/min, mobile phase ratio was Phosphate buffer (0.05M) pH 4.6: ACN   (55:45%v/v)   (pH   was   adjusted   with   orthophosphoric acid), detection wave length was 255nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, PDA Detector 996, Empower-software version-2. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study for wa donepezil and memantine s found in   concentration range of   1μg-5μg   and   100μg-500μg   and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100% and 100.5%, %RSD for repeatability was 0.2 and 0.4, % RSD for intermediate precision was 0.5 and 0.1 respectively.
Keywords: Donepezil, Memantine, RP-HPLC, Phosphate buffer, CAN

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