痤疮灵霜中诺氟沙星含量测定及不确定度评价  

Content Determination Of Norfloxacin in Cuochuanglin Cream and Uncertainty Evaluation

作　　者：马晓静[1] 崔业波[1] 程焱 MA Xiao-jing;CUI Ye-bo;CHENG-yan(Siping Institute for Food and Drug ControL,Siping 136000,China)

机构地区：[1]四平市食品药品检验所,吉林四平136000

出　　处：《解放军药学学报》2018年第5期416-419,共4页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立HPLC法测定痤疮灵霜中诺氟沙星的含量,并对测定结果的不确定度进行分析,明确不确定度来源。方法以Agilent ZORBAX SB-C18(5μm,4.6mm×250mm)为色谱柱;0.025mol·L-1磷酸溶液(用三乙胺调节pH值至3.0±0.1)-乙腈(87∶13)为流动相;检测波长:278nm;柱温:30℃。分析各因素对含量测定结果的影响,计算合成不确定度并确定测量结果在95%置信区间下的扩展不确定度。结果诺氟沙星在4.84~58.03μg·ml-1的线性范围内呈良好的线性关系,平均回收率为100.1%,RSD为0.3%(n=6),HPLC法测定诺氟沙星的扩展不确定度为2.98%。结论采用HPLC法测定痤疮灵霜中诺氟沙星含量的方法简便可靠,专属性强,重复性好,可用于痤疮灵霜的质量控制。通过对该方法的不确定度分析,对照品的称量是本次试验不确定度的主要来源。Objective To establish an HPLC method to determine the content of norfloxacin in Cuochuanglincream and to analyze the causes of uncertainty.Methods The optimum HPLC condition was as follows：Agilent Zobax SB-C18（4.6 mm×250 mm,5μm）column with a mobile phase composd of 0.025 mol·L-1 phosphoric acid（triethylamine was used to modulate the pH to 3.0±0.1）and acetonitrile（87∶13）.The flow rate was 1.0 ml·min-1.The detection wavelength was 278 nm and the column temperature was 30℃.The influence of each factor on the determination of content was analyzed.The combined uncertainty and finally the extended uncertainty were obtained in 95% confidence intervals.Results There was good linearity in the range of 4.84 to 58.03μg·ml-1.The average recovery was 100.1%,RSD=0.3%（n =6）.The expanded uncertainty for the HPLC determination of norfloxacin was 2.98%.Conclusion This method is simple and reliable with strong specificity and reproducibility,which can be used for quality control of Cuochuanglingcream.The uncertainty of the experiment is mainly caused by the weight of the standard.

关 键 词：痤疮灵霜 诺氟沙星 含量测定 不确定度 HPLC 

分 类 号：R917[医药卫生—药物分析学]