【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。更多还原

【Abstract】 Objective; To establish a RP-HPLC method for quantification of thiamphenicol glyci-nate 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 20μL. Results: The linearity of the TGH concentration was in a range of 40 - 400μg·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.更多还原