Srilakshmi V

A new rapid, precise and sensitive reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the estimation of Atazanavir and Ritonavir simultaneously in combined dosage form. The two components Atazanavir and Ritonavir were well resolved on an isocratic method, C18 column, utilizing a mobile phase composition of acetonitrile: 0.02M ammonium acetate buffer (40:60), v/v, pH 4.0) at a flow rate of 1.0 mL/min with UV detection at 205 nm. The retention time of Atazanavir and Ritonavir were 2.8 min and 5.7 min respectively. The developed method was validated for specificity, linearity, precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and robustness as per ICH guidelines. Linearity for Atazanavir and Ritonavir were found in the range of 18.0-42.0 µg/ml and 5.0-14.0 µg/ml, respectively. The percentage recoveries for Atazanavir and Ritonavir ranged from 98.9-101.0 % and 98.2-100.1 %, respectively. The proposed method could be used for routine analysis of Atazanavir and Ritonavir in their combined dosage forms.

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.