A pre-column derivatization technique for the development and validation of a stability indicating HPLC-UV method for the determination of memantine in bulk and formulations by using (2-napthoxy) acetyl chloride

摘要

A simple, specific, precise, and accurate stability indicating RP-HPLC method has been developed and validated by using (2-Napthoxy) Acetyl chloride as derivatization agent and Amantadine as an internal standard. The separation was achieved by Inertsil ODS-3V, 250 x 4.6, 5μm column using mobile phase consisting of 0.02 M ammonium acetate buffer and methanol in the ratio (12:88) at a flow rate of 1.5 mL/min and UV detection at 226 nm. The Method was developed in isocratic mode. The retention time for Memantine and Amantadine was around 8.62 and 6.23. The method showed linearity with correlation coefficient 0.999 over the range of 3.1-18.57 μg/mL. The mean recoveries were found to be in the range of 98.5--99.9% for Memantine Hydrochloride.LOD and LOQ values were found to be 0.12 and 0.32g/mL respectively. The method was validated as per the ICH guidelines for linearity, limit of detection, limit of quantification, accuracy, precision, robustness and solution stability. Stability indicating capability of the developed method was established by analyzing forced degradation of samples with separation of degradation products from analytes peak was achieved. The method can be successfully applied for routine analysis of quantitative determination of Memantine Hydrochloride in pharmaceutical dosage form.