Determination of granisetron by various analytical methods

Granisetron hydrochloride (GRA) is an antiserotonergic antiemetic drug and is used to prevent emesis after chemotherapy. In this study a capillary electrophoresis (KE) and a high performance liquid chromatographic (YPSK) method were developed for the determination of GRA in pharmaceutical formulations. Metoprolol succinate (MTP) was used as an internal standard (IS) in the methods. In KE method, detection was achieved by diode array detection at 205.5 nm and separation was achieved by a capillary of 75 µm i.d. and 40 cm effective length. Optimum conditions were found as 20 mM phosphate buffer (pH 2,75) and applied voltage of 22.5 kV. Under these circumstances, the migration times for GRA and IS were 6.71 min and 6.94 min respectively. In YPSK method, detection was achieved by fluorescence detector with an excitation wavelength of 223 nm and an emission wavelength of 340 nm. For the separation a C6 phenyl column (3.0×150.0 mm, 5.0 µm i.d.) and as a mobile phase 30 mM acetate buffer:methanol (7:3, v/v) (pH 4.0) system was used at a flow rate of 0,85 mL/min. In this method retention times for GRA and IS were 4.57 min 2.95 min, respectively. The validation of the developed methods were examined by linearity, precision, accuracy, sensitivity, stability, specificity and robustness parameters. The limits of quantification of the methods were 4,30×10-7 M for KE and 2,04×10-8 M for YPSK method. Both of the developed methods were successfully applied to GRA tablets and ampoules and the contents were found to be in the limits of USP39. The developed methods are proposed for the routine analyses of GRA. Keywords: Granisetron, Capillary Electrophoresis, High Performance Liquid Chromatography, Tablet, Ampoule.