RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF VIBEGRON IN PURE AND PHARMACEUTICAL DOSAGE FORM
AbstractAn accurate, sensitive, precise, fast isocratic reverse phase HPLC technique has been developed and validated for the quantification of Vibegron in the pure and pharmaceutical dosage form. The best separation was achieved on a 250 mm x 4.6 mm ID., 5µ-particle size Inertsil®-Octadecyl-Silyl-3V-Reverse-Phase-C18-column with 0.05M Ammonium dihydrogen orthophosphate in water: acetonitrile (60:40 v/ v) as mobile phase solvent at a speed of 1.0 ml/ min in the isocratic mode of elution. UV detection was observed at 238 nm. Retention time of Vibegron was found to be 4.0 minutes. With a correlation coefficient of about 0.9989, peak-response was obtained as function of concentration of Vibegron over the range of 80 to 240 µg/ ml. Vibegron had shown to have a percentage assay of 110.05 %. It had a limit of detection (LOD) and a limit of quantification (LOQ) of 0.1 µg/ ml and 0.3 µg/ ml, respectively. The presence of excipients in the formulation had no effect on the assay method. The procedure is swift and precise and can be employed appropriately for use in QC- laboratories.
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