AN IMPROVED RP-HPLC METHOD FOR THE QUANTITATIVE DETERMINATION AND VALIDATION OF LEVETIRACETAM IN BULK AND PHARMACEUTICAL FORMULATION

Abstract

For the first time a convenient, simple, specific, accurate, precise, rapid, inexpensive isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Retigabine in pharmaceutical tablet dosage form. RP-HPLC method was developed by utilizing Welchrom C18 Column (4.6 X 250 mm, 5µm), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase composed of 10 mM Phosphate buffer: acetonitrile (50:50 v/v) (pH-3.0, adjusted with triethylamine). The flow rate was set to 1.0 mL.min-1 with the responses measured at 302.8 nm using Shimadzu SPD-20A Prominence UV-Visible detector. The retention time of Retigabine was found to be 5.670 minutes. Linearity was established for Retigabine in the range of 2-10 µg.mL-1 with correlation coefficient 0.9997. The LOD and the LOQ were found to be 0.1658 μg.mL-1 and 0.5025 μg.mL-1 respectively. The amount of Retigabine present in the formulation was found to be 99.90 %. The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation. The developed method can be utilized for regular quality control analysis of Retigabine in pharmaceutical dosage form.