Abstract

The main objective of this study is to develop and validate a novel, simple, new, fast, sensitive, precise and accurate RP-HPLC analytical methods have been established for the estimation of cefotaxime sodium in bulk and pharmaceutical dosage forms. The present method was developed and validated on a Waters HPLC system using Phenomenex make Shimadzu C18 column (250mm × 4.6mm i.d., 5μm particle size) column was used for the separation. Best results were obtained with the mobile phase composition consisting of Acetonitrile water (70:30, v/v). The system was regulated at 1.0 ml/min flow rate at 233nm UV detection. Cefotaxime sodium was eluted at 2.622 min retention time. The analytical parameters such as accuracy, precision, linearity, LOD, LOQ, ruggedness, and robustness were used for validating the developed method according to ICH guidelines. Linearity was exhibited over the concentration range of 0.01-0.07µg/ml and the Limit of Detection and Quantitation values for cefotaxime sodium were 1.8ng/ml and 5.8ng/ml respectively. The result of analysis shows that the amount of drugs present in the formulation has a very good correlation with the label claim of the formulation and % RSD will be less than 2 for all the validation parameters. Recoveries studies revealed that results within the specified limits. The developed methods were validated for various parameters as per ICH guidelines. Hence the proposed method was found to be satisfactory and could be used for the routine analysis of cefotaxime sodium in their marketed formulation.

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