DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF RANOLAZINE IN BULK AND TABLET DOSAGE FORM

Abstract

An isocratic reverse phase liquid chromatography (RP-HPLC) method has been developed and subsequently validated for the determination of Ranolazine in Bulk and its pharmaceutical formulation. Separation was achieved with a X-terra c8 (Make: Waters Corporation; 150 mm × 4.6 mm I.D.; particle size 5 µm) Column and Sodium di-hydrogen phosphate buffer in water (pH adjusted to 5.0 with diluted orthophosphoric acid): Acetonitrile (600:400) v/v as eluent at a flow rate of 1.0 mL/min. UV detection was performed at 210 nm. The method is simple, rapid, and selective. The described method of Ranolazine is linear over a range of 50-150 µg/mL The method precision for the determination of assay was below 2.0%RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 98% to 101%. The results showed that the proposed method is suitable for the precise, accurate and rapid determination of Ranolazine in bulk, its Tablets dosage forms.