Asian Journal of Research in Chemistry

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Fast LC Method for Determination of Cefditoren Pivoxil and its Related Impurities in Bulk and Pharmaceutical Formulations


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1 School of Chemistry, Andhra University, Visakhapatnam, India
     

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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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  • Fast LC Method for Determination of Cefditoren Pivoxil and its Related Impurities in Bulk and Pharmaceutical Formulations

Abstract Views: 265  |  PDF Views: 1

Authors

R. Narendra Kumar
School of Chemistry, Andhra University, Visakhapatnam, India
G. Nageswara Rao
School of Chemistry, Andhra University, Visakhapatnam, India
P. Y. Naidu
School of Chemistry, Andhra University, Visakhapatnam, India

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.