Analytical Method Development and Validation for the Estimation of Lecanemab Using RP-HPLC

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Lecanemab in pharmaceutical dosage form. Chromatographic separation of Lecanemab was achieved on Waters Alliance e-2695, by using Agilent Zorbax SB C18 (250×4.6 mm, 5μ) column and the mobile phase containing Methanol and 0.1M Ammonium formate pH-3.0/OPA in the ratio of 80:20 % v/v. The flow rate was 1.0 ml/min; detection was carried out at 229 nm using a photodiode array (PDA) detector at ambient temperature. The theoretical plates and tailing factor for Lecanemab were NLT 2000 and not more than 2 respectively. % Relative standard deviation of peak areas of all measurements was always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate and robust for the quantitative analysis of Lecanemab.