A kind of assay method of amorolfine hydrochloride and its interfering substances
A technique for the determination of amorolfine hydrochloride, which is applied in the field of analysis and detection of pharmaceutical components, can solve the problems of failing to take into account the separation of mobile phase components, ratios, interfering substances, increased production costs, and various mobile phase components.
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Embodiment 1
[0078] 1. Experimental part
[0079] 1.1 Sample pretreatment
[0080] The preparation of need testing solution: take amorolfine hydrochloride emulsifiable paste sample, add the methanol solution that contains 0.4~0.6% phosphoric acid, vortex instrument oscillation shakes 15~25min, the quality that amorolfine hydrochloride emulsifiable paste sample adds ( g), and the ratio of the volume (ml) added to the phosphoric acid-containing methanol solution is 3:14 to 3:16. Then, sonicate at 45-55°C for 10-20 minutes, cool to room temperature, dilute with pure water to volume, then shake well, refrigerate and centrifuge, filter, and take the filtrate as the test solution. Wherein, the conditions of refrigerated centrifugation are as follows: the centrifugation temperature is -5-0° C.; the centrifugation time is 15-30 minutes; the centrifugation speed is 8000-14000 rpm. Filtration is 0.45 μm membrane filtration.
[0081]Preparation of the reference substance solution: Weigh the amorol...
Embodiment 2
[0098] 1. Experimental part
[0099] 1.1 Sample pretreatment
[0100] The preparation of need testing solution: precision takes amorolfine hydrochloride emulsifiable paste sample 3g, puts in 25ml measuring bottle, adds the methanol solution 15ml that contains 0.5% phosphoric acid and shakes for 20min, the amorolfine hydrochloride emulsifiable paste sample adds The ratio of the mass (g) to the volume (ml) of the phosphoric acid-containing methanol solution is 3:15. Then, sonicate in a water bath at 50°C for 15 minutes, cool to 20-25°C, dilute to volume with pure water, shake well, refrigerate and centrifuge, filter, and take the filtrate as the test solution. Wherein, the conditions of refrigerated centrifugation are as follows: the centrifugation temperature is 0° C.; the centrifugation time is 15-30 min; and the centrifugation speed is 8000-14000 rpm. Filtration is 0.45 μm membrane filtration.
[0101] Preparation of the reference substance solution: Weigh the amorolfine h...
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