Validated high-performance thin-layer chromatographic (HPTLC) method for simultaneous determination of nadifloxacin, mometasone furoate, and miconazole nitrate cream using fractional factorial design

Abstract

A high-performance thin-layer chromatographic method for simultaneous determination of nadifloxacin, mometasone furoate, and miconazole nitrate was developed and validated as per International Conference on Harmonization guidelines. High-performance thin-layer chromatographic separation was performed on aluminum plates precoated with silica gel 60F and methanol:ethyl acetate:toluene: acetonitrile:3M ammonium formate in water (1:2.5:6.0:0.3:0.2, % v/v) as optimized mobile phase at detection wavelength of 224 nm. The retardation factor (R) values for nadifloxacin, mometasone furoate, and miconazole nitrate were 0.23, 0.70, and 0.59, respectively. Percent recoveries in terms of accuracy for the marketed formulation were found to be 98.35-99.76%, 99.36-99.65%, and 99.16-100.25% for nadifloxacin, mometasone furoate, and miconazole nitrate, respectively. The pooled percent relative standard deviation for repeatability and intermediate precision studies was found to be < 2% for three target analytes. The effect of four independent variables, methanol content in total mobile phase, wavelength, chamber saturation time, and solvent front, was evaluated by fractional factorial design for robustness testing. Amongst all four factors, volume of methanol in mobile phase appeared to have a possibly significant effect on retention factor of miconazole nitrate compared with the other two drugs nadifloxacin and mometasone furoate, and therefore it was important to be carefully controlled. In summary, a novel, simple, accurate, reproducible, and robust high-performance thin-layer chromatographic method was developed, which would be of use in quality control of these cream formulations.

Structure‐retention relationship for enantioseparation of selected fluoroquinolones

“…The proposed methods have been successfully used for the determination of GFLX in opthalmic solution, OFLX in tablets, and NFLX in cream formulation with good accuracy and precision (Table ). Statistical comparison between results of pharmaceutical analyses obtained by the proposed and reported or official method for GFLX, OFLX, and NFLX showed no significant difference at .05 probability.…”

Application of TLC-Spectrodensitometric and Chemometric Methods for Determination of Momenta® Cream: A Comparative Study Applied on Ternary Mixture

“…Mometasone Furoate (MF) is a glucocorticoid or corticosteroid used topically to reduce inflammation of the skin or in the airways; inflammatory skin disorders (such as eczema and psoriasis) (topical form), allergic rhinitis (such as hay fever) (topical form), and asthma (inhalation form). A review of the literature showed that methods reported for the determination of (MF) alone or in combinations were spectrophotometry [1][2][3], HPLC [4][5][6][7][8][9][10][11][12][13][14][15], HPTLC [7,[16][17][18], electrochemical method [19], and LC [20]. Miconazole Nitrate (MIC) an imidazole antifungal agent that is used topically and by intravenous infusion, miconazole nitrate is the nitrate salt form of miconazole, an antifungal synthetic derivative of imidazole and used in the treatment of candidal skin infections.…”

Assessment of Fractional Factorial Design for the Selection andScreening of Appropriate Components of a Self-nanoemulsifyingDrug Delivery System Formulation

“…26 To the best our knowledge, no study has reported on the application of FFD for screening and selecting appropriate components during SNEDDS formulation. FFD has been successfully applied for choosing the appropriate conditions for Cu(II) extraction from soybean-based organic solvent, 27 robustness testing of analytical methods, 28,29 assessing the effect of process parameters, 30,31 and determining optimized conditions for material synthesis. 32…”