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Abstract
Pharmaceutical Care and Research: 2018; 18(3):203-206
DOI: 10.5428/pcar20180311
Contents determination of ketoconazole,clobetasol propionat and neomycin sulfate in compound ketoconazole cream
1. CHEN FangJian(Department of Pharmacy,Changhai Hospital,Second Military Medical University, Shanghai 200433,China ngchenfangjian@126.com)
2. WANG XiaoJun(Department of Pharmacy,Changhai Hospital,Second Military Medical University, Shanghai 200433,China junwx0929@sina.com)
3. LU SongWei(Department of Pharmacy,Changhai Hospital,Second Military Medical University, Shanghai 200433,China )
4. YU HuiHua(Department of Pharmacy,Changhai Hospital,Second Military Medical University, Shanghai 200433,China )
5. SONG HongJie(Department of Pharmacy,Changhai Hospital,Second Military Medical University, Shanghai 200433,China h_jsong@126.com)
ABSTRACT  Objective: To establish HPLC method and microbiological assay method for contents determination of ketoconazole, clobetasol propionat and neomycin sulfate in compound ketoconazole cream. Methods:The contents of ketoconazole and clobetasol propionat were determined by HPLC method.The separation column of Kromasil 100-5 C18(150 mm×4.6 mm,5 μm) was used. Methanol-0.02 mol/L sodium dihydrogen phosphate(containing 0.15% triethylamine,68∶32) was applied as the mobile phase.The flow rate was 1.0 ml/min and the column temperature was set at room temperature.The detection wavelength was 239 nm and the sample size was 20 μl.The two-dose assay of incylinder-plate method of microbiological assay was used to determine the potency of neomycin sulfate with staphylococcus aureus as the tester strain.Results:Ketoconazole and clobetasol propionat displayed good linearity within the range of 25-800 μg/ml(r=0.999 9) and 0.625-20 μg/ml(r=0.999 9), respectively. The average recoveries were 98.52%(RSD 1.33%,n=6) and 97.60% (RSD 1.44%,n=6),respectively.The regression of neomycin sulfate was very significant(P<0.01).The parallel deviate was not significant(P>0.05).The reliability test results were established.The confidence-limit rate(FL%) of the experiment results was good.Conclusion: The two methods are accurate,sensitive,specific and reproducible,which could provide the reference for heightening the quality standards of compound ketoconazole cream.
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Please cite this article as:
CHEN FangJian,WANG XiaoJun,LU SongWei,YU HuiHua,SONG HongJie,. Contents determination of ketoconazole,clobetasol propionat and neomycin sulfate in compound ketoconazole cream[J]. Pharmaceutical Care and Research / yao xue fu wu yu yan jiu. 2018; 18(3): 203-206.
References:
1. State Pharmacopoeia Committee.Pharmacopoeia of the People’s Republic of China.2015 ed.Volume 4[S].Beijing:Chinese Medical Science Press,2015:160-165, 182-200.In Chinese.
2. State Pharmacopoeia Committee.Pharmacopoeia of the People’s Republic of China.2015 ed.Volume 2[S].Beijing:Chinese Medical Science Press,2015:823-824,148,1460-1461.In Chinese.
3. LIAO HuiYi,SHEN Fang,HUANG LiJing.HPLC determination of ketoconazole and clobetasol propionate in clonazole cream[J].Chin J Pharm Anal,2002,22(5):395-397.In Chinese with English abstract.
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