RP-HPLC法测定甲砜霉素及其胶囊剂的含量和有关物质  

RP - HPLC Determination of Thiamphenicol and Content and Related Substance in Its Capsules

作　　者：秦峰[1] 陈佳[1] 陈桂良[1] 仇士林[1] 

机构地区：[1]上海市药品检验所,上海200233

出　　处：《药物分析杂志》2004年第5期532-535,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:采用反相高效液相色谱法测定甲砜霉素及其胶囊剂的含量及有关物质。方法:采用Merck C18色谱柱(250 mm×4.0 mm,5μm);以乙腈-水(1:4)为流动相;流速1.2 mL·min-1;检测波长:225 nm;柱温:30℃;进样量:10μL。结果:含量测定的线性范围为20.29—203.9 μg·mL～1,r=0.9999(n=7);有关物质测定的线性范围为2.072—20.72μg·mL-1;r=0.9998(n=7),甲砜霉素胶囊的加样回收率为101.3%,99.2%,98.9%;RSD依次为1.9%,0.4%,0.7%(n=3)。结论:本法简便快速、准确,专属性好。Objective:To establish a RP - HPLC method for the determination of thiamphenicol and related substances in its capsules. Method:Using a Merck ODS column(250 mm ×4. 0 mm,5 μm). The mobile phase consisted acetonitrile - water( 1:4). The flow rate was 1. 2 mL · min-1. The detection wavelenth was 225 nm. The column temperature was 30℃. Inject volume was 10 μL. Result: The linear range for the content of thiamphenicol was 20.29 -203.9 μg · mL-1 ,r =0.9999(n =7) and for Its related substances was 2.072 -20. 72 μg · mL-1 ,r = 0. 9998(n =7). The recoveries of thiamphenicol capsules were 101. 3% ,99. 2% ,98.9% and Its RSD were 1. 9% , 0.4% ,0. 7%(n=3). Conclution: The method is simple, rapid, accurate and is suitable for the determination of thiamphenicol and its related substances.

关 键 词：有关物质 胶囊剂 甲砜霉素 RP—HPLC法 含量测定 反相高效液相色谱法 RSD C18色谱柱 流动相 快速 

分 类 号：R927[医药卫生—药学] R286.0