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

作　　者：Ganji Ramanaiah D. Ramachandran G. Srinivas Jayapal Gowardhane Purnachanda Rao Srilakshmi. V 

机构地区：[1]Department of Chemistry, Acharya Nagarjuna University Nuzivid Campus, Andhra Pradesh, India

出　　处：《American Journal of Analytical Chemistry》2012年第5期378-384,共7页美国分析化学（英文）

摘　　要：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.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.

关 键 词：RANOLAZINE RP-LC VALIDATION DOSAGE FORM 

分 类 号：R73[医药卫生—肿瘤]