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.
Highlights
Ranolazine [1,2,3] (Figure 1) a piperazine derivative is a new antianginal agent approved for the treatment of chronic stable angina pectoris
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
Summary
Ranolazine [1,2,3] (Figure 1) a piperazine derivative is a new antianginal agent approved for the treatment of chronic stable angina pectoris. Ranolazine has antianginal and anti-ischemic effects that do not depend upon reductions in heart rate or blood pressure. Ranolazine reduces the late sodium current and, is expected to decrease sodium entry into ischemic myocardial cells. Ranolazine is proposed to reduce calcium uptake indirectly via the sodium/calcium exchanger. It has a cardio protective effect against ischemia or reperfusion injury, without affecting hemo-dynamics, both in vitro and in vivo. There are certain methods reported in literature for estimation of Ranolazine by LC-MS, LC and UV methods, besides they lack of stability indication, complicated sample processing procedures, low sensitivity and time consuming gradient elution
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