Abstract
A simple, accurate, precise RP-HPLC method was developed for Zolmitriptan determination in bulk and in formulation. The use of chromatographic conditions such as YMC-Pack ODS-AQ column (150 mm x 4.6 mm i.d, 5 µm particle size) as stationary phase, 0.05M potassium dihydrogen orthophosphate buffer (pH 4): acetonitrile (90: 10) as mobile phase with isocratic elution mode. The flow rate was set at 1.0 ml/ minutes. The detection wavelength of 210 nm was optimized to attain a good chromatographic separation. The retention time was noticed to be 9.15 minutes for the drug, Zolmitriptan. The proposed method was applied to the fast disintegrating Zolmitriptan sublingual tablets and the percentage assay was found to be 101.9%.This method was confirmed by system suitability, precision, specificity, linearity and range, accuracy, limit of detection, limit of quantification and robustness as per ICH recommended guidelines. The linearity was established over a concentration range of 25 to 150 µg/ml with a value of 0.999 as correlation coefficient. The mean recovery percentage of Zolmitriptan was attained to be 99.96%. The method was precise with percentage RSD value less than 0.2.
