目的 建立同時(shí)測定聯(lián)苯芐唑乳膏中8種抑菌劑和1種抗氧劑含量的方法。方法 采用CAPCELL PAK ADME色譜柱，以0.02 mol/L乙酸銨溶液-甲醇為流動(dòng)相，梯度洗脫，體積流量為1.0 mL/min，柱溫為30℃，檢測波長為218 nm。進(jìn)行專屬性、線性關(guān)系、檢測限與定量限、精密度、回收率、穩(wěn)定性等方法學(xué)考察。檢測來自13家生產(chǎn)企業(yè)、共37批次聯(lián)苯芐唑乳膏中抑菌劑山梨酸、苯甲酸、苯甲醇、尼泊金甲酯、尼泊金乙酯、尼泊金丙酯、尼泊金丁酯、苯扎溴銨和抗氧劑二丁基羥基甲苯（BHT）的含量。結(jié)果 抑菌劑山梨酸、苯甲酸、苯甲醇、尼泊金甲酯、尼泊金乙酯、尼泊金丙酯、尼泊金丁酯、苯扎溴銨和抗氧劑BHT的線性范圍分別為9.924~198.5、10.43~208.6、24.94~498.7、10.07~201.5、10.13~202.6、10.13~202.5、10.03~200.5、4.053~81.04、10.10~202.0 μg/mL（r為0.999 3~1.000 0）；平均回收率為98.6%~100.9%（RSD為0.52%~1.43%）。專屬性、檢測限與定量限、精密度、穩(wěn)定性等方法學(xué)考察均符合要求。各批次苯芐唑乳膏均未檢出苯甲酸、尼泊金甲酯、尼泊金丙酯和尼泊金丁酯，檢出山梨酸、苯甲醇、尼泊金乙酯、苯扎溴銨和BHT。結(jié)論 建立的方法操作簡便、結(jié)果準(zhǔn)確，可用于聯(lián)苯芐唑乳膏中抑菌劑和抗氧劑含量的同時(shí)測定。

Objective To establish a method for simultaneous determination of eight bacteriostats and one antioxygen in Bifonazole Cream. Methods The determination was performed on CAPCELL PAK ADME column with mobile phase consisted of 0.02 mol/L ammonium acetate solution-methanol in gradient elution at a flow rate of 1.0 mL/min. The column temperature was 30℃, and detection wavelength was set at 218 nm. The specificity, linear relationship, limit of detection and limit of quantitation, precision, recovery, stability were investigated. The contents of sorbic acid, benzoic acid, benzyl alcohol, methyl paraben, ethyl paraben, propyl paraben, butyl paraben, benzalkonium bromide and antioxidant dibutyl hydroxytoluene (BHT) in 37 batches of Bifonazole Cream from 13 manufacturers were determined. Results The linear range of bacteriostats sorbic acid, benzoic acid, benzyl alcohol, methylparaben, ethylparaben,propylparaben,butylparaben,benzalkonium bromide and antioxygen BHT were 9.924-198.5, 10.43-208.6, 24.94-498.7, 10.07-201.5, 10.13-202.6, 10.13-202.5, 10.03-200.5, 4.053-81.04, 10.10-202.0 μg/mL(r=0.999 3-1.000 0)respectively. The average recoveries were 98.6%-100.9% with the RSDs of 0.52%-1.43%. The specificity, limit of detection and limit of quantification, precision, stability and other methodological investigation met the requirements. Benzoic acid, methyl paraben, propyl paraben and butyl paraben were not detected in all batches of benzimidazole cream, but sorbic acid, benzyl alcohol, ethyl Paraben, benzalkonium bromide and BHT were detected. Conclusions The method is simple and accurate, and can be used for simultaneous determination of bacteriostats and antioxygen in Bifonazole Cream.

R927.2