Abstract
A new, simple and sensitive spectrofluorimetric method is developed for the determination of levetiracetam (LEV). The proposed method is based upon its reaction with 9-Fluorenylmethyl chloroformate (FMOC-Cl) in borate buffer of pH 10 to produce a highly fluorescent derivative at λ emission 308 nm after excitation at 265 nm. All parameters required for the reaction conditions are investigated. Linearity is verified with a range of 5 - 50 ng mL-1. Validation of the procedure is evaluated according to ICH guidelines and shows good accuracy and reproducibility, with mean percentage recovery 99.89%. The Correlation Coefficient is 0.9998 (n = 6), with limit of detection 1.1 ng mL-1 and limit of quantification 3.3 ng mL-1. The proposed method is applied for analysis of LEV in its different dosage forms (tablets and syrup) with percentage assay (100.4 ± 1.2% RSD and 100.3 ± 0.71% RSD respectively) without interference from common additives. Statistical analysis of the results reveals no significant difference between the data of the proposed method with those of the reported method (t-test = 0.615 and F-test = 8.327).
