Simultaneous Determination of 4 Components in Compound Metronidazole Clindamycin Cream by HPLC / 中国药房

ABSTRACT

OBJECTIVE:To establish the method for simultaneous determination of the content of metronidazole,clindamycin hydrochloride,spironolactone and vitamin B6 in Compound metronidazole clindamycin cream.METHODS:HPLC method was adopted.The determination was performed on Diamonsil C18 column with mobile phase consisted of acetonitrile-[0.68％ dipotassium hydrogen phosphate solution (containing 1％ triethylamine)] (gradient elution) at the flow rate of 1.0 mL/min.The detection wavelength was set at 210 nm,and column temperature was 25 ℃.The sample size was 20 μL.RESULTS:The linear ranges of metronidazole,clindamycin hydrochloride,spironolactone and vitamin B8 were respectively 20.0-120.0 i.tg/mL(r=0.999 9),10.0-60.0μg/mL(r=0.999 1),4.0-24.0 μg/mL(r=0.999 4),10.0-60.0 μg/mL (r=0.999 4).The quantitative limits were respectively 13.06,7.36,2.43,6.42 μg/mL.The detection limits were 4.18,1.82,0.76,1.79 μg/mL.RSDs of the precision,stability,repeatability tests were all less than 2％.The recovery rates were respectively 98.97％-100.91％ (RSD=0.79％,n=9),99.02％-101.80％ (RSD=1.03％,n=9),98.18％-101.05％ (RSD=1.01％,n=9) and 98.75％-101.36％ (RSD=0.87％,n=9).CONCLUSIONS:The method is simple,rapid,accurate and can be used for the determination of metronidazole,clindamycin hydrochloride,spironolactone and vitamin B6 in Compound clindamycin metronidazole cream.