mometasone-furoate and nadifloxacin

Nadifloxacin, mometasone furoate and miconazole nitrate are formulated together as a topical antifungal dosage form. In this work, a reversed-phase ultra-performance liquid chromatographic method coupled with a diode array detector (RP-UPLC-DAD) was developed and validated to determine nadifloxacin, mometasone furoate and miconazole nitrate simultaneously in their bulk powder, in pharmaceutical preparation and in spiked human plasma samples. Separation was achieved on an ACQUITY UPLC C18 column of 2.2 μm particle size (2.1 × 100 mm) via isocratic elution using a mobile phase consisting of methanol, acetonitrile and water with ratio (50:20:30; v/v/v) and 0.1 g ammonium acetate, then pH was adjusted to (7.00) using acetic acid, flow rate 0.6 mL/min, temperature 30°C and UV detection at 220 nm. The method is linear in a range from 5 to 400 μg/mL for both nadifloxacin and miconazole nitrate and from 20 to 500 μg/mL for mometasone furoate. The method was validated according to the ICH guidelines then applied successfully to determine the mentioned drugs in their pharmaceutical preparation and spiked human plasma samples. For plasma samples, the results showed that the method can determine nadifloxacin, mometasone furoate and miconazole nitrate in human plasma samples with high accuracy and precision.

Topics: Chromatography, High Pressure Liquid; Chromatography, Reverse-Phase; Fluoroquinolones; Humans; Limit of Detection; Linear Models; Miconazole; Mometasone Furoate; Quinolizines; Reproducibility of Results

A novel and simple ultra-performance LC method was developed for the estimation of nadifloxacin (NAD), terbinafine hydrochloride (TBH), mometasone furoate (MMF), methyl paraben (MP), and propyl paraben (PP) in a topical pharmaceutical dosage formulation. The analysis was carried out on a Waters Acquity UPLC ethylene bridged hybrid C18 column (50 × 2.1 mm, 1.7 μm) with a flow rate of 0.4 mL/min in gradient mode at a wavelength of 255 nm. Elution of all components was achieved within 9 min. The retention times of MP, NAD, PP, TBH, and MMF were observed at 1.5, 2.6, 3.4, 6.0, and 6.9 min, respectively. The proposed method was validated per current International Conference on Harmonization guidelines for specificity, precision, linearity, accuracy, range, LOD, LOQ, robustness, filter paper interference, and solution stability parameters. A complete method study was performed to determine the stability-indicating nature of the developed method.

Topics: Chromatography, High Pressure Liquid; Drug Stability; Fluoroquinolones; Limit of Detection; Mometasone Furoate; Naphthalenes; Parabens; Pharmaceutical Preparations; Quinolizines; Reproducibility of Results; Terbinafine

In recent years inhibitors directed against the epidermal growth factor receptor (EGFR) have evolved as effective targeting cancer drugs. Characteristic papulopustular exanthemas, often described as acneiform rashes, are the most frequent adverse effect associated with this class of novel cancer drugs and develop in > 90% of patients. Notably, the rash may significantly compromise the patients' quality of life, thereby potentially leading to incompliance as well as dose reduction or even termination of the anti-EGFR therapy. Yet, an effective dermatologic management of cutaneous adverse effects can be achieved. Whereas various case reports, case series or expert opinions on the management of EGFR-inhibitor (EGFRI) induced rashes have been published, data on systematic management studies are sparse.. Here, we present a retrospective, uncontrolled, comparative study in 49 patients on three established regimens for the management of EGFRI-associated rashes.. Strikingly, patients' rash severity improved significantly over three weeks of treatment with topical mometason furoate cream, topical prednicarbate cream plus nadifloxacin cream, as well as topical prednicarbate cream plus nadifloxacin cream plus systemic isotretinoin.. In summary our results demonstrate that EGFRI-associated rashes can be effectively managed by specific dermatologic interventions. Whereas mild to moderate rashes should be treated with basic measures in combination with topical glucocorticosteroids or combined regiments using glucocorticosteroids and antiseptics/antibiotics, more severe or therapy-resistant rashes are likely to respond with the addition of systemic retinoids.

Topics: Administration, Topical; ErbB Receptors; Exanthema; Fluoroquinolones; Humans; Isotretinoin; Mometasone Furoate; Pregnadienediols; Protein Kinase Inhibitors; Quinolizines