Determination of Gemifloxacin in human plasma by high performance liquid chromatography using Ultra Violet detector and its application to a bioequivalence study

A liquid chromatography method was developed and validated for the determination of gemifloxacin in human plasma using chloramphenicol as internal standard to achieve lower quantification limit. Acetonitrile was used to precipitated and extracted analyte and internal standard from plasma by Protein Precipitation. Analysis was performed isocratically on C18 column using 25% acetonitrile and 75% 0.02 M phosphate buffer as mobile phase. The method was demonstrated to be linear from 0.003 µg/mL to 5 µg/mL with the lower limit of quantitation of 0.003 µg/mL. The method was successfully applied for the bioequivalence study of gemifloxacin after a single oral administration of 320 mg gemifloxacin mesylate tablets to 12 healthy volunteers.

本研究开发并验证了一种液相色谱法，用于测定人血浆中的吉米沙星，以氯霉素作为内标（internal standard）以实现更低的定量下限。采用乙腈通过蛋白质沉淀法（Protein Precipitation）从血浆中沉淀并萃取待测物与内标。分析采用等度洗脱模式，在C18色谱柱上进行，以25%乙腈与75% 0.02 mol/L磷酸盐缓冲液作为流动相。该方法的线性范围为0.003 μg/mL至5 μg/mL，定量下限为0.003 μg/mL。本方法已成功应用于12名健康受试者单次口服320 mg甲磺酸吉米沙星片后的吉米沙星生物等效性研究。