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Gemifloxacin (Factive, LB20304a), a new chemical entity developed by LG Life Science Ltd. and approved by FDA on April 2003, is broad-spectrum fluoroquinolone antibiotic used to treat respiratory infections. It was synthesized by the coupling reaction of the two key intermediates, 7-chloro1-cyclopropyl-fluoro-1,4-dihydro-4-oxo-1,8-naphthylidine3-carboxylic acid (QN09) and 3-aminomethyl-4-hydroxypyrrolidine (AM19), as shown in Figure 1. Recently, we have developed a new QN09 synthetic process that is more cost-effective, operationally simpler than the previous one. The QN09 has two impurities and three intermediates that were not found in QN09 synthesized by the previous process. The impurities and intermediates were not separated completely from QN09 by using high performance liquid chromatographic (HPLC) separation conditions that was applied to analysis of QN09 produced by the previous synthetic process. The report on the previous analytical method and its validation is registered on the LG Life Science’s Drug Master File of Gemifloxacin. The objective of this study is to develop and validate the analytical method by which QN09 is separated and determined from the impurities and intermediates produced by the new synthetic process. The new analytical method for the assay of QN09 has baseline separation with its degradation products, the new impurities and the intermediates with the resolution of 8 and the number of theoretical plates of > 20000. The method validation was done by evaluating specificity, linearity, accuracy, precision (i.e., repeatability and intermediate precision), robustness and solution stability complying with the International Conference on Harmonization (ICH) guideline Q2(R1). The new assay of QN09 was applied for the production of FACTIVE. The validation result will be reported to FDA. Experimental

Method Validation for HPLC Assay of 7-Chloro-1-cyclopropyl-fluoro-1,4-dihydro-4-oxo-1,8-naphthylidine-3-carboxylic acid