盐酸洛美沙星原药及其注射液中有关物质的HPLC-FLD法测定

Determination of Related Substances of Lomefloxacin Hydrochloride and Its Injection by HPLC-FLD

建立了高效液相色谱-荧光检测法测定盐酸洛美沙星及其注射液中的有关物质。采用C_(18)色谱柱,以0.67 mol/L磷酸盐缓冲液(pH 3.0)-甲醇-四氢呋喃(79.2:20:0.8,含四丁基硫酸氢铵1.0mg/ml、磷酸0.2%)为流动相,荧光检测,激发波长278 nm,发射波长434 nm。洛美沙星在0.16～8μg/ml浓度范围内线性关系良好,回收率为100.4%,日内和日间RSD为0.36%和0.53%。

An HPLC-FLD method was established for the determination ot the relateo suostances of lomefloxacin hydrochloride and its injection. A C18 column was used with the mobile phase of 0.67 mol/L phosphate buffer （pH 3.0）-methanol-tetrahydrofuran （79.2 ： 20 ： 0.8, containing 1.0 mg/ml tetrabutylammonium hydrogensulfate and 0.2 % phosphoric acid） at excitation wavelength of 278 nm and emission wavelength of 434 nm. The calibration curve was linear in the concentration range of 0.16 - 8 μg/ml. The recovery was 100.4 % with the intra- and inter-RSDs of 0.36% and 0.53%.