Abstract

DEVELOPMENT AND VALIDATION OF CEFUROXIME AXETIL BY SPECTROPHOTOMETRIC AND CHROMATOGRAPHIC METHOD IN BULK AND PHARMACEUTICAL DOSAGE FORM

Priyanka S. Patil*, Prof. Smita Aher and Prof. Dr. R. S. Bacchav

ABSTRACT

Objective: Objective of the present analytical research work was to develop and validate simple, accurate, precise and specific zero and first order UV-spectrophotometric method by area under curve technique and Reversed phase-High performance liquid chromatography (RP-HPLC method) for the determination Cefuroxime Axetil bulk and pharmaceutical dosage form. Methods: Method A (UV- Spectrophotometry method): The stock and working standard solution of the drugs were prepared in methanol. Standard solution were scanned over the range of 400-200nm in spectrum mode of spectrophotometer at medium scanning speed using UV spectrophotometer. The maximum absorbance for CFA was found at 281nm. 1) Derivative spectrophotometric method: Zero order derivative spectra with area under curve method (270.0nm and 293.80nm). And first order derivative spectra with area under curve (272.6 nm and 298nm) cefuroxime axetil in methanol. Method B (RP-HPLC method): The RP-HPLC method for CFA was developed using Agilent infinitylab poroshell 120 as stationary particle. Isocratic mode Acetonitrile: Double distilled water: Phosphate buffer pH 6.8 (40:50:10) as mobile phase. Mobile phase at a flow rate of 1.0ml/min and detection was carried out at 281nm. Results: Cefuroxime axetil was found to be linear in the concentration range of 5-35 mcg/ml for spectrophotometric method was found to be 99% the amount of CFA in pharmaceutical dosage form by RP-HPLC method was found to be 99.8%. Both the methods were validated in accordance with ICH guidelines.

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