Sat, 18 Nov 2017

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

 

Ramanaiah Ganji*1, Ramachandran D. 1, Srinivas G. , Srilakshmi V., Purnachanda Rao

 

1. Department of Chemistry, Acharya Nagarjuna University Nuzivid Campus, Andhra Pradesh, India.


 

ABSTRACT

An isocratic reverse phase liquid chromatography (RP-LC) method has been developed and subsequently validated for the determination of Lacosamide in Bulk and its pharmaceutical formulation. Separation was achieved with a Xterra RP-8 ((Make: Waters Corporation; 150 mmx4.6 mm I.D; particle size 5 µm)) Column and Sodium di-hydrogen phosphate monohydrate buffer (pH adjusted to 3.0 with diluted orthophosphoric acid): Acetonitrile (800:200) v/v as eluent at a flow rate of 1.0 ml/min. UV detection was performed at 230nm. The method is simple, rapid, and selective. The described method of Lacosamide is linear over a range of 12.0µg/ml to 37.85 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 99.3 to 100.9%. The results showed that the proposed method is suitable for the precise, accurate and rapid determination of Lacosamide in bulk, its dosage forms.

Key Words: Lacosamide, RP-LC, Validation, Dosage form.


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