Dosage form.

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.

  A rapid and sensitive UV-Visible spectroscopic method was developed for the estimation of Ranalozine in pure and its Pharmaceutical formulations. The method was validated as per International Conference on Harmonization [ICH] guidelines. The Ranalozine was monitored at 230nm with UV detection and there is interference of diluent at 230nm for Ranalozine. The method was linear (r2 =0.999) at concentration ranging from 12 to 40μg/ml, precise (intra-day relative standard deviation [RSD] and inter-day RSD values < 1.0%), accurate (mean recovery = 100.2%), specific and robust. The results showed that the proposed method is suitable for the precise, accurate and rapid determination of Ranalozine in bulk, its capsule dosage forms. Key Words: Ranalozine, UV-Visible spectroscopy, Validation, Dosage form.