4. Development and validation of RP-HPLC method for the determination of riluzole hydrochloride in bulk and tablet dosage forms

A reverse-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of riluzole hydrochloride in bulk and tablet dosage forms. The separation was achieved on BDS hypersil ODS analytical column (100 mm × 4.6 mm i.d., 3.0 μm) using 5M ammonium acetate and acetonitrile in the ratio 50:50 v/v as mobile phase and at a flow rate of 1.0 mL/min. Detection was carried out using a PDA detector at 220 nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The developed and validated method was successfully applied for the quantitative analysis of Rilutek tablets. The total chromatographic analysis time per sample was about 5 min with riluzole hydrochloride eluting at retention time of about 2.452 min. The method was validated as per ICH guide lines. Validation studies demonstrated that the proposed HPLC method is simple, specific, rapid, reliable and reproducible. The standard curves were linear over the concentration range of 50-400 μg/mL. The LOD and LOQ values for riluzole hydrochloride were 0.02 and 0.09 μg/mL, respectively. The percentage recovery was found to be 99.59 to 100.97 and the %RSD for intraday and inter day precision was found to be 0.503, 0.494, respectively. The high recovery and low relative standard deviation confirm the suitability of the proposed method for the determination of riluzole hydrochloride in bulk and tablet dosage forms.