Analytical Method Development and Validation for Simultaneous Estimation of Nadifloxacin and Mometasone Furoate in Semisolid Dosage Form by RP-HPLC Method

Abstract

The goal was to develop and validate an easy, affordable, fast, reliable, reproducible, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) technique for estimating Nadifloxacin and Mometasone furoate in semisolid dose form. Mometasone Furoate is medium-strength corticosteroids used to treat skin conditions. The HPLC system with a C-18(2) column (250 x 4.6 mm, particle size 5 µm) operating at a wavelength of 254 nm was used to carry out the chromatographic separation.  NADIREST-M, a cream with chlorocresol as a preservative, is the available dosage form.  As a result, the interference of Chlorocresol was calculated as well, and there was no interference in the estimation of both medications by evaluating system suitable parameters (Chlorocresol peak has resolution greater than 2 from the peak of drug). In the concentration range of 50-130 µgmL-1 and 5-13 µgmL-1 Nadifloxacin and Mometasone Furoate respectively, the detector response was found linear with linear regressed equation Y=15116X-365319 and Y=52717X-184314. In the assay of NADI, 99.12% and MOM 99.77% of the drug was recovered. As per ICH requirements, this method demonstrated satisfactory validation for all criteria such as accuracy, linearity, specificity, precision, range, ruggedness, robustness, and repeatability.  The study's findings demonstrated that it is useful for routinely determining Nadifloxacin and Mometasone Furoate in semisolid pharmaceutical dose forms such as a cream.