RP-HPLC法测定注射用甲砜霉素甘氨酸酯盐酸盐的含量和有关物质  

RP-HPLC quantification of thiamphenicol glycinate hydrochloride for injection and the related substances

作　　者：张蓓[1] 王东凯[1] 宋涛[1] 杨秀丽[1] 王海凤[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中国新药杂志》2006年第17期1473-1475,共3页Chinese Journal of New Drugs

摘　　要：目的:采用反相高效液相色谱法测定注射用甲砜霉素甘氨酸酯盐酸盐(TGH)含量及有关物质。方法:采用色谱柱:Diamonsil C18柱(250 mm×4．6 mm,5μm);流动相:0．01 mol·L-1三氟乙酸-乙腈(88:12);流速: 1．0 mL·min-1;紫外检测波长:223 nm;进样体积:20μL;柱温:40℃。结果:含量测定的线性范围为40—400μg·mL-1,r=0．999 9(n=5),注射用TGH的加样回收率为98．4％-100．3％;RSD在0．29％-1．08％。结论:本法简便快速、准确,专属性好。Objective： To establish a RP-HPLC method for quantification of thiamphenicol glycinate hydrochloride （TGH）for injection and the related substances. Methods： The RP-HPLC condition was consisted of a Diamonsil C18 column （250 mm × 4.6 mm ,5μm） with a column temperature at 40 ℃ , mobile phase of acetonitrile-0.01 mol·L^-1 trifluoroacetic acid （88： 12） with a flow rate of 1.2 mL·min^-1, and detection wavelength at 223 nm. The loading volume of the TGH was 20 μL. Results： The linearity of the TGH concentration was in a range of 40 ～ 400 μg · mL^-1 （ r = 0. 999 9, n = 5 ）. The recoveries of TGH were in the range of 98.4% ～ 100.3% with RSD of 0. 29% ～ 1.08%. Conclusion ： The specific, reliable and accurate RP-HPLC method is applied to quality control of TGH and the related substances.

关 键 词：甲砜霉素甘氨酸酯盐酸盐 反相高效液相色谱法 含量测定 有关物质 

分 类 号：R927.2[医药卫生—药学]