高效液相色谱法测定消毒乳膏中非法添加的抗真菌药物

Determination of antifungal drugs illegally added in disinfection cream by high performance liquid chromatography

目的 建立同时测定消字号乳膏中灰黄霉素、酮康唑、联苯苄唑、克霉唑、硝酸益康唑、硝酸咪康唑、盐酸萘替芬和盐酸特比萘芬等8种抗真菌药物的高效液相色谱法。方法 采用CAPCELL PAK C18(250 mm×4.6 mm×5μm)色谱柱分离,以乙腈-水为流动相,梯度洗脱,220 nm波长检测,外标法定量消毒乳膏中非法添加的抗真菌药物成分。结果 8种抗真菌组分在0.06~20.86μg/mL范围内线性关系良好(相关系数r=0.999 9),检出限和定量限分别为1.95~6.95 mg/kg和5.85~20.86 mg/kg,平均加标回收率为92.92%~104.05%,相对标准偏差为1.25%~3.80%。市售的20批消字号乳膏中8批样品检出硝酸咪康唑,含量为8.8~23.7 mg/g, 1批样品检出酮康唑,含量为9.7 mg/g。结论 高效液相色谱法可同时测定消字号乳膏中非法添加的8种抗真菌药物。

Objective To establish a high performance liquid chromatography method for the simultaneous determination of eight antifungal drugs in griseofulvin, ketoconazole, bifonazole, clotrimazole, econazole nitrate, miconazole nitrate, naftifen hydrochloride and terbinafine hydrochloride in the anti-faxin cream. Methods CAPCELL PAK C18(250 mm×4.6 mm×5 μm) column was used for separation, acetonitrile-water was used as mobile phase, gradient elution and 220 nm wavelength was used, and the antifungal components illegally added in the disinfection cream were quantified by external standard. Results The eight antifungal components had good linear relationship in the range of 0.06-20.86 μg/mL(correlation coefficient r=0.9999), and the detection limit and the limit of quantification were 1.95-6.95 mg/kg and 5.85-20.86 mg/kg, respectively. The average spiked recovery rate was 92.92%-104.05%, and the relative standard deviation was 1.25%-3.80%. Among the 20 batches of commercially available anti-brand creams, 8 batches of samples were detected with miconazole nitrate with a content in the range of 8.8-23.7 mg/g, and 1 batch of samples was detected with ketoconazole with a content of 9.7 mg/g Conclusion High performance liquid chromatography can simultaneously determine 8 antifungal drugs illegally added to the antifungal cream.