医院制剂米诺地尔酊定量方法的建立与应用  

Minoxidil tincture of minoxidil content control

作　　者：黄久遂[1] 蔡素芬[1] 徐晓[1] HUANG Jiusui;CAI sufen;XU Xiao(Guangzhou Institute of Dermatology,Guangzhou 510095,China)

机构地区：[1]广州市皮肤病防治所,广东广州510095

出　　处：《现代医院》2020年第5期750-752,共3页Modern Hospitals

摘　　要：目的为提高医院制剂质量标准,建立医院制剂米诺地尔酊中米诺地尔含量测定的方法并用于该制剂的质量控制中。方法采用反相高效液相色谱法。色谱柱为Eclipse XDB-C18柱(250 mm×4.6 mm,5μm),柱温:25℃,以甲醇-水(70∶30)(每1 000 m L中含磺基丁二酸钠二辛酯3.0 g和1 m L冰醋酸,并用高氯酸调节p H值至3.0)为流动相,流速为1.0 m L/min,检测波长为240 nm。结果米诺地尔在0.019 54~0.097 68 mg/m L浓度范围内,线性关系良好(r=0.999 8),测得平均回收率为99.54%,RSD为0.18%。结论本法准确可靠,可用于医院制剂米诺地尔酊的质量控制。Objective To establish a method for minoxidil tincture of minoxidil content control.Methods HPLC column was Eclipse XDB-C18(250 mm×4.6 mm,5μm)and column temperature was 25℃.The mobile phase was methanol-water-acetic acid glacial(per 1 000 m L contains dioctylis sulfosuccinas natricus 3.0 g,perchloric acid was used to adjust the p H to 3.0)(70∶30∶1)and the flow rate of 1.0 m L/min,the detecting wavelength was at 240 nm.Results The linear range of minoxidil was 0.019 54~0.097 68 mg/m L(r=0.999 8)and the average recovery was 99.54%,RSD=0.18%.Conclusion this method is reliable and accurate for the quality control of minoxidil tincture.

关 键 词：米诺地尔酊 米诺地尔 HPLC 含量测定 

分 类 号：R927[医药卫生—药学]