• RAM S. SAKHARE
• PRANITA D. NAIKNAWARE
• AISHWARYA H. GAHERWAR
• MOEIN. S. ATTAR

A Novel simple, Accurate, precise, specific, sensitive and robust Reverse Phase High performance liquid chromatography (RP-HPLC) method was developed and validated. Design Expert® (11.0.0) modeling software (Stat-Ease Inc., Minneapolis, MN, USA) was used for response surface methodology (RSM). The selected CMPs (critical method parameter) were systematically optimized using Central-composite design (CCD). Chromatographic separation was accomplished on Agilent C18 (50 x 2.1 mm, 1.7µm) analytical column and UV detection was set at 230 nm. The optimized and predicted data from Design Expert software consisted of mobile phase 0.01N Potassium dihydrogen phosphate: acetonitrile in 55.2:44.8 v/v proportion, as it is pumped at a flow rate of 1 ml/min. The developed chromatographic approach was validated according to ICH Q2 (R1) guidelines.

Memantine HCl, Donepezil, RP-HPLC, QbD Method.

"“QUALITY BY DESIGN BASED RP-HPLC ASSAY METHOD DEVELOPMENT AND VALIDATION OF MEMANTINE HCL AND DONEPEZIL HCL IN PHARMACEUTICAL DOSAGE FORM”", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 4, page no.300-314, April-2023, Available :http://www.jetir.org/papers/JETIRFW06040.pdf

"“QUALITY BY DESIGN BASED RP-HPLC ASSAY METHOD DEVELOPMENT AND VALIDATION OF MEMANTINE HCL AND DONEPEZIL HCL IN PHARMACEUTICAL DOSAGE FORM”", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 4, page no. pp300-314, April-2023, Available at : http://www.jetir.org/papers/JETIRFW06040.pdf