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.

中文翻译：

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联用物理分离和色谱分离分析含咪康唑、糠酸莫米松和硫酸庆大霉素的乳膏

针对 Momenta® 乳膏中的咪康唑、莫米松和庆大霉素开发、验证并应用了高效液相色谱法。由于三种组分的溶解度不同，因此使用两种提取程序进行物理分离。首先，将含有咪康唑和莫米松的乳膏的甲醇提取物在 ODS-3 Inertsil C18 柱（150 × 4.6，5 μm）上使用乙腈：水（80:20，v/v）作为流动相，流速 1.5 进行色谱分离mL·min−1，在 230 nm 下扫描，莫米松和咪康唑的 tR 分别为 2.817 和 6.808 分钟。其次，将含有庆大霉素的乳膏的水提取物用邻苯二甲醛衍生化，以增强庆大霉素 UV 检测，并在 Inertsil ODS-3 C18 柱（150 × 4.6，5 μm）上进行离子对色谱，使用甲醇：0 . 025 M 庚烷磺酸：冰醋酸（75:20:5，体积比）为流动相，流速 0.8 mL·min−1，在 330 nm 扫描，其中三种活性庆大霉素异构体在 tR 11.7、15.6 处分离和 18.3 分钟。根据 ICH 指南进行验证，证明了该方法对药物定量评估的适用性。该方法具有选择性、精确性和准确性，因此可用于 QC 实验室中的乳膏配方分析。