硝酸咪康唑乳膏中防腐剂测定方法的建立

Construction of a Method to Determine the Antiseptics in Miconazole Nitrate Cream

目的建立测定硝酸咪康唑乳膏中防腐剂含量的高效液相色谱法。方法色谱柱为Diamonsilc，C18柱（250mm×4．6mm，5μm），以0．05mol／L磷酸二氢钾-乙腈（72：28）为流动相，检测波长为235nm。结果苯甲酸、山梨酸、羟苯乙酯的检出限分别为4．77，5．26，10．24ng，进样量线性范围分别12．5～200μg，5—80μg，25～400μg，相关系数分别为0．99996，0．99997，0．99991（n=6）。结论该方法操作简单、重复性好、检测结果准确，能更好地检测硝酸咪康唑乳膏中防腐剂的含量。

Objective To establish a method to determine the antiseptics in Miconazole Nitrate Cream. Methods The HPLC analysis was performed on Diamonsil C18（250 mm× 4. 6 mm, 5μm）column;the mobile phase consisted of 0. 05 mol/L monopotassium phosphate and acetonitrile（72：28） ;the detective wavelength was 235 nm. Results The limit of detection was 4. 77,5.26 and 10.24 ng for ben- zoic,sorbic acid and ethylhydroxybenzoate respectively. It had good linear relationsbip at the range of 12. 5 -200 μg,5-80 μg, 25- 400 μg respectively and the correlation coefficient was 0. 999 96,0.999 97 and 0.999 91（n=6） for benzoic,sorbic acid and ethylhy- droxybenzoate respectively. Conclusion The method is simple,good in repeatability,accurate for quantitation and can be used for deter- mining the antiseptics in Miconazole Nitrate Cream.