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Development and Validation of a Simple Method for Simultaneous Estimation of Memantine and Donepezil in Pharmaceutical Dosage Forms by Using RP-HPLC
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| Author:
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MD SATTAR*, SUNEETHA ACHANTA
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| Abstract:
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A new method was established for simultaneous estimation of Memantine and Donepezil by RP-HPLC method. The
chromatographic conditions were successfully developed for the separation of Memantine and Donepezil by using
Hypersil BDS C18 column (250×4.6mm) 5.0µm, flow rate was 1.0ml/min, mobile phase ratio was (60:40 v/v) Potassium
dihydrogen o-phosphate Buffer: AcetonitritepH 6.0 (pH was adjusted with Ortho-phosphoric acid),detectiowavelength
was 232nm. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, UV detector 2487,
Empower-software version-2. The retention times of Memantine 2.147mins and Donepezil were found to be 3.49 mins.
The % purity of Memantine and Donepezil and was found to be 100.26% and 99.29% respectively. The system suitability
parameters for Memantine and Donepezilsuch as theoretical plates and tailing factor were found to be 2524.84 and
1.65,3177, 1.57 and the resolution was found to be 6.0. The analytical method was validated according to ICH guidelines
(ICH, Q2 (R1)). The linearity study of Memantine and Donepezil was found in concentration range of 5µg-25µg and
5µg-25µg and correlation coefficient (r2) was found to be 0.999 and 0.999, % recovery was found to be 100.84% and
99.59%, %RSD for repeatability was 0.17 and 0.15, % RSD forintermediate precision was 1.05 and 0.06 respectively. The
precision study was precise, robust, and repeatable.LOD value was2.98 and 2.96, and LOQ value was 9.96 and
9.98respectively.
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| Keyword:
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Hypersil BDS C18 column, Memantine, Donepezil and , RP-HPLC
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| EOI:
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| DOI:
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