Development and Validation of Stability Indicating RP-LC Method for Estimation of Ranolazine in Bulk and Its Pharmaceutical Formulations

Abstract

An isocratic reverse phase liquid chromatography (RP-LC) 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 RP-18 ((Make: Waters Corporation; 150 mm × 4.6 mm I.D.; particle size 5 μm)) Column and Sodium di-hydrogen phosphate monohydrate buffer with Tri ethyl amine (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 225 nm. The method is simple, rapid, and selective. The described method of Ranolazine is linear over a range of 11.98 μg/mL to 37.92 μg/mL. The method precision for the determination of assay was below 1.0%RSD. The percentage recoveries of active pharmaceutical ingredient (API) from dosage forms ranged from 99.1% to 100.9%. The results showed that the proposed method is suitable for the precise, accurate and rapid determination of Ranolazine in bulk, its capsule dosage forms.