T/SXITS 0003-2021 Determination of Eight Antifungal Components in Disinfecting Cream Formulations Using Ultra-high Performance Liquid Chromatography-Tandem Mass Spectrometry (UHPLC-MS/MS)

Scope

Main technical content: 1. Specifies the principle, reagents and materials, instruments and equipment, analysis steps, result presentation, precision, detection limit, and quantification limit of high-performance liquid chromatography-tandem mass spectrometry for the determination of eight antifungal chemicals in Xiaozhengzi ointment. 2. Applies to the qualitative and quantitative determination of eight antifungal chemicals in Xiaozhengzi ointment, including miconazole, econazole, ketoconazole, griseofulvin, bifonazole, naftifine, clotrimazole, and terbinafine. 3. When the sample weight is 0.5 g and the sample volume is 50 mL, the detection limit of griseofulvin is 140 μg/kg, and the quantification limit is 400 μg/kg; the detection limits of clotrimazole, ketoconazole, terbinafine, and econazole are 70 μg/kg, and the quantification limits are 200 μg/kg; the detection limits of bifonazole, miconazole, and naftifine are 30 μg/kg, and the quantification limits are 100 μg/kg.

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