HPLC法同时测定复方甲硝唑克林霉素乳膏中4种成分的含量

Simultaneous Determination of 4 Components in Compound Metronidazole Clindamycin Cream by HPLC

目的:建立同时测定复方甲硝唑克林霉素乳膏中甲硝唑、盐酸克林霉素、螺内酯、维生素B_6含量的方法。方法:采用高效液相色谱法。色谱柱为Diamonsil C_(18),流动相为乙腈-[0.68%磷酸氢二钾溶液(含1%三乙胺)](梯度洗脱),流速为1.0 mL/min,检测波长为210 nm,柱温为25℃,进样量为20μL。结果:甲硝唑、盐酸克林霉素、螺内酯、维生素B_6检测质量浓度线性范围分别为20.0～120.0μg/mL(r=0.999 9)、10.0～60.0μg/mL(r=0.999 1)、4.0～24.0μg/mL(r=0.999 4)、10.0～60.0μg/mL(r=0.999 4);定量限分别为13.06、7.36、2.43、6.42μg/mL,检测限分别为4.18、1.82、0.76、1.79μg/mL;精密度、稳定性、重复性试验的RSD<2.0%;回收率分别为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)、98.75%～101.36%(RSD=0.87%,n=9)。结论:该方法简便、快速、结果准确,可用于复方甲硝唑克林霉素乳膏中甲硝唑、盐酸克林霉素、螺内酯、维生素B_6含量的同时测定。

OBJECTIVE： To establish the method for simultaneous determination of the content of metronidazole, clindamycin hydrochloride, spironolactone and vitamin Be in Compound metronidazole clindamycin cream. METHODS： HPLC method was ad- opted. 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 wave- length was set at 210 nm, and column temperature was 25 ℃. The sample size was 20 μL. RESULTS： The linear ranges of metroni- dazole, clindamycin hydrochloride, spironolactone and vitamin B6 were respectively 20.0-120.0 μg/mL（r= 0.999 9）, 10.0-60.0 μg/mL（r=0.999 1）, 4.0-24.0 μg/mL（r=0.999 4）, 10.0-60.0 μ/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=l.01% , n=9） and 98.75% -101.36% （RSD=0.87% , n=9）. CONCLU- SIONS： The method is simple, rapid, accurate and can be used for the determination of metronidazole, clindamycin hydrochlo- ride, spironolactone and vitamin Be in Compound clindamycin metronidazole cream.