A NEW ISOCRATIC RP-HPLC METHOD DEVELOPMENT FOR THE ASSAY OF GRANISETRON HCl IN API AND DOSAGE FORMS

摘要

An isocratic RP-HPLC method has been developed and validated for the assay of Granisetron HCl in active pharmaceutical ingredient (API) and pharmaceutical dosage forms. The chromatographic determination was performed on Shimadzu HPLC (LC2010AHT) system equipped with an LC-10A VP quaternary pump, a variablewavelength programmable UV-Visible detector, 20-μL injection loop and a Gemini NX C18 (250mm × 4.6mm, 5μm) reversed phase column using 0.01M sodium dihydrogen phosphate buffer of pH 7.5 and acetonitrile in the ratio 80:20 v/v as mobile phase at a flow rate of 1.5mL.min?1. The chromatographic data was acquired by using Class-VP 5.032 software. The eluent was monitored at wavelength 305nm and found a sharp and symmetrical peak with retention time of 7.466min, USP plate count of 2944.62 and tailing factor of 1.3. The linearity of the proposed method was in the range of concentration 2.0-10.0μg.mL-1. The limit of detection (LOD) and limit of quantification (LOQ) of the developed method were found to be 0.1502μg.mL-1 0.4553μg.mL-1 respectively. The proposed method was found to be precise, accurate and sensitive. Hence, this method can be applied as an alternative for the assay of Granisetron HCl in quality control.