Asian Journal of Research in Chemistry

R. Narendra Kumar ¹, G. Nageswara Rao ¹, P. Y. Naidu ¹

Affiliations
1 School of Chemistry, Andhra University, Visakhapatnam, IN

Abstract

A Fast LC method has been developed and subsequently validated for the determination of Cefditoren pivoxil and its related impurities in bulk and pharmaceutical formulation. Separation was achieved in Gradient mode using Hypersil BDS, C18, 100 x 4.6 mm, 3μm column with mobile phase A containing Ammonium formate buffer (pH adjusted to 6.0±0.05 with formic acid solution) and mobile phase B containing Methanol and Acetonitrile (40:60 v/v) at different time intervals as eluent at a flow rate 1.2ml/min. UV detection was performed at 230nm. The method is simple, rapid, and selective and stability indicating. The described method is linear over a range of 200.34μg/mL to 1520.56μg/mL. The method precision for the determination of assay was below 2.0% RSD .The Percentage recoveries of Active Pharmaceutical Ingredient (API) from dosage form is 99.2. LOD and LOQ of all related impurities of Cefditoren pivoxil was established and ranged from 0.0431μg/ml - 0.1843μg/ml for LOD and 0.1292μg/ml - 0.6014μg/ml for LOQ. The method is useful in the quality control of bulk manufacturing and also in pharmaceutical formulations.

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R. Narendra Kumar , G. Nageswara Rao , P. Y. Naidu

Abstract

An isocratic stability indicating liquid chromatographic method has been developed and validated for the determination of Eszopiclone in bulk drug and its pharmaceutical dosage form. Separation of the drug with degradation products was achieved using Peerless HT, C8, 50×4.6 mm; 1.8 μm column as stationary phase and pH 4.5(±0.05) buffer:Acetonitrile:Tetrahydrofuran (81:18:1, v/v) as mobile phase at a flow rate of 1.0 mL/min. UV detection was performed at 304 nm. The method is linear over the range of 10-150 μg/mL. The percent recovery of drug in dosage forms was ranged from 97.7 to 100.5. The method is simple, rapid, precise, selective and stability indicating and can be used for the assay in quality control and stability studies samples.

Keywords

Bird Flu, Chemsketch, Docking, Hex, Rasmol.

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