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Abstract
BIOANALYTICAL METHOD DEVELOPMENT AND ESTIMATION OF CEFOTAXIME USING RP-HPLC
Ankush Pushptode* Ankit Diwan, Kuldeep Ganju
Sagar Institute of Pharmacy and Technology, Bhopal (M.P), India
ABSTRACT
A Bioanalytical RP-HPLC assay method has been developed and validated for cefotaxime. An isocratic RP-HPLC method was developed with C18 column (250 mm ×4.6 mm i.d., 5 µm) utilizing a mobile phase of 20mM KH2P4 and acetonitrile (80:20 v/v) with UV detection at wavelength 260 nm at the flow rate 1.0ml/min. The proposed method was validated for sensitivity, selectivity, linearity, accuracy,
precision, ruggedness, robustness and solution stability. The response of the drug was linear in the concentration range of 5-25µg/ml. Limit of detection and Limit of quantification was found to be 0.57µg/ml and 1.54µg/ml respectively. The % recovery ranged within 99.466±0.313 - 99.825±0.269%.
Method, system, interday and intraday precision was found to be within the limits of acceptance criteria. Method was found to be rugged when analysis was carried out by different analyst. The method was suitable for the quality control of cefotaxime in injection formulations.
Keywords: Cefotaxime, Bioanalytical, Method development, Validation.
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