METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF NADIFLOXACIN AND MOMETASONE FUROATE USING HPLC
Monish Bari, Sushma Somkuwar, Akhlesh Kumar Singhai
ABSTRACT
A simple, precise, accurate, and robust reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Nadifloxacin (NFC) and Mometasone Furoate (MSF) in pharmaceutical dosage forms. Chromatographic separation was achieved using a C18 column (250 mm × 4.6 mm, 5 µm) with a mobile phase consisting of 10 mM KH?PO? and methanol in the ratio of 20:80 (v/v), maintained at a flow rate of 1.0 mL/min. Detection was carried out at 254 nm. The retention times for NFC and MSF were found to be approximately 3.77 min and 5.97 min, respectively. The method was validated in accordance with ICH guidelines. Linearity was observed over the concentration range of 1–5 µg/mL for NFC and 2–10 µg/mL for MSF, with correlation coefficients of 0.9985 and 0.9996, respectively. The method demonstrated good accuracy, with percentage recoveries ranging from 98.57% to 99.03% for NFC and 98.77% to 99.28% for MSF. Precision studies showed %RSD values less than 2%, indicating high reproducibility. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.10µg/mL and 0.32µg/mL for NFC, and 0.25 µg/mL and 0.75 µg/mL for MSF, respectively. The developed method was successfully applied for the assay of pharmaceutical formulation, with assay values of 98.00% for NFC and 99.00% for MSF. The proposed method is suitable for routine quality control analysis of Nadifloxacin and Mometasone Furoate in combined dosage forms.
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