Coupling of Physical and Chromatographic Separation for Analyzing Cream Containing Miconazole, Mometasone Furoate and Gentamicin Sulphate.

High-performance liquid chromatographic method was developed, validated and applied for miconazole, mometasone and gentamicin in Momenta® cream. Physical separation was applied using two extraction procedures due to different solubility of the three components. First, a methanolic extract of the cream contained miconazole and mometasone was chromatographed on ODS-3 Inertsil C18 column (150 × 4.6, 5 µm) using acetonitrile: water (80:20, v/v) as a mobile phase, flow rate 1.5 mL·min-1, scanned at 230 nm, showing tR 2.817 and 6.808 min for mometasone and miconazole, respectively. Second, an aqueous extract of the cream containing gentamicin was derivatized with o-phthalaldehyde in order to enhance the gentamicin UV detection and subjected to ion pairing chromatography on Inertsil ODS-3 C18 column (150 × 4.6, 5 µm), using methanol: 0.025 M heptane sulphonic acid: glacial acetic acid (75:20:5, by volume) as a mobile phase, flow rate 0.8 mL·min-1, scanned at 330 nm where the three active gentamicin isomers were separated at tR 11.7, 15.6 and 18.3 min. Suitability of this method for quantitative estimation of the drugs was proved by validation according to ICH guidelines. The method was selective, precise and accurate so could be used for analysis of cream formulation in QC labs.

A Validated Ultra-Performance Liquid Chromatographic Method for the Simultaneous Determination of Nadifloxacin, Mometasone Furoate and Miconazole Nitrate in Their Combined Dosage Form and Spiked Human Plasma Samples.

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.