Lacosamide is a novel antiepileptic drug and is a member of a family of functionalized amino acids, more specifically, analogues of the endogenous amino acid and NMDA-receptor modulator D-serine from BCS Class-I substance (High solubility, High permeability). As per our knowledge, no dissolution method is reported for estimation of lacosamide in tablet dosage form. So, our aim is to develop and validate a simple, accurate, precise, economic dissolution method for estimation of Lacosamide using spectroscopic method. Based on solubility study 500 ml of 0.1 N HCl and distilled water as a dissolution medium was tried for method development using paddle type apparatus with stirring speed of 50 and 75 rpm at a physiological temperature (37±0.5ºC). Sampling was carried out up to 60 min at a different time interval. Optimal conditions to carry out the dissolution were 500 ml of 0.1 N HCl as dissolution medium using paddle at 75 rpm stirring speed with detection by UV spectroscopy at 257.20 nm which was able to give 99.37% drug release. Linearity of developed method was found in the range of 50-150 µg/ml with 0.9998 correlation co-efficient. Limit of detection and Limit of quantification of developed method was 1.5464 and 4.8663 respectively. The Percentage recovery for the developed method was found in the range of 100.33-101.11, 99.53-100.00 and 100.24-100.81 % for Lacasa 50, Lacosam 50 and Lacosam 100 respectively. Analytical method validation was found to be within the acceptance criteria of the guidelines of ICH Q2 R1, FDA and FIP. So, developed method is new advancement for routine quality control analysis for pharmaceutical industry.
Loading....