Development and Validation of RP-HPLC Method for Simultaneous Determination of Cefotaxime Sodium and Sulbactum Sodium in Bulk and Injection

Author(s): Rohan S. Badgujar, Saurabh Kumar Banerjee and G. Venkateshwarlu

A reverse phase high performance liquid chromatographic method was developed for simultaneous determination of cefotaxime sodium and sulbactum sodium in bulk and injection. The separation was made by a Phenomenex Gemini C18 column (250 cm × 4.6 mm, 5 μm) using buffer (40% tetrabutyl ammonium hydrochloride) : acetonitrile : methanol (8 : 1.75 : 0.25, v/v/v) as mobile phase. The validation of the method was performed, and specificity, reproducibility, precision and accuracy were confirmed. The limit of detection was approximately 0.57 μg/mL for cefotaxime sodium and 0.49 μg/mL for sulbactum sodium. Due to simplicity and accuracy, the method is particularly suitable for routine pharmaceutical quality control.

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