SPECTROSCOPIC METHOD DEVELOPMENT & VALIDATION FOR ESTIMATION OF MICAFUNGIN USING DYE DRUG REACTION
Givanshu Sen, Ankit Diwan, Kuldeep Ganju
ABSTRACT
A simple, rapid, and precise UV–visible spectrophotometric method was developed and validated for the estimation of Micafungin (MFG) in bulk and tablet formulations. The method showed maximum absorbance (?max) at 433.0 nm and exhibited excellent linearity in the range of 2–10 µg/mL (r² = 0.9982). Accuracy was confirmed through recovery studies at 80%, 100%, and 120% levels, with mean recoveries ranging from 98.09% to 99.14% and %RSD <2%. Precision studies including repeatability, day-to-day variation, analyst-to-analyst variation, and reproducibility showed low %RSD values, indicating the method is highly precise and reliable. The method was successfully applied to commercial tablet formulations, giving assay results of 99.70% ± 0.145% RSD. The proposed method is simple, accurate, precise, and suitable for routine quality control of MFG in pharmaceutical formulations.
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