摘要
目的建立高效液相色谱法测定盐酸地芬尼多片的含量与有关物质的方法。方法采用VP-ODSC18色谱柱(4.6mm×250mm,5μm),以0.5%三乙胺溶液(用磷酸调节pH值至4.0)-甲醇(44∶56)为流动相;流速为0.8mL·min-1;检测波长为210nm,柱温:30℃。结果盐酸地芬尼多与有关物质及各降解成分完全分离;盐酸地芬尼多浓度在3.158～63.15mg·L-1内与峰面积呈良好线性关系,r=1.0000(n=7);最低检出限为1ng,最低定量限为3ng;低、中、高3种浓度的回收率(n=3)分别为100.4%(RSD=0.4%),99.5%(RSD=0.8%),99.8%(RSD=0.4%)。结论该方法操作简便、快速、准确,灵敏度高,可用于盐酸地芬尼多片含量及有关物质的测定。
OBJECTIVE To establish a HPLC method for the determination of content and related substances in difenidol hydrochloride tablets. METHODS The separation was performed on a VP-ODS C18 column （4.6 mm×250 mm,5 μm）. The mobile phase consisted of 0.5% triethylamine solution （adjusted to pH 4.0 with phosphoric acid ）-methanol （44∶56） and the flow rate was 0.8 mL·min-1. The detection wavelength was 210 nm and the column temperature was 30 ℃. RESULTS Related substances and degraded substances were completely separated from difenidol hydrochloride. The linear range of determination was 3.158～63.15 mg·L-1 with the correlation coefficient of 1.000 0 （n=7）,and the LOD was 1 ng. LOQ was 3 ng. The average recoveries （n=3） of low,middle and high concentration were 100.4% （RSD=0.4%）,99.5% （RSD=0.8%） and 99.8% （RSD=0.4%）. CONCLUSION The method is simple,rapid,accurate,sensitive and it is suitable for the determination of the content and related substances in difenidol hydrochloride tablets.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2009年第22期1748-1751,共4页
Chinese Pharmaceutical Journal
关键词
盐酸地芬尼多片
含量
有关物质
difenidol hydrochloride tablets
content
related substances
