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

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Kim, Hoon-Joo (Research & Development, LG Life Sciences, Ltd.) ;
Kim, Young-Suk (Research & Development, LG Life Sciences, Ltd.) ;
Kim, Dong-Min (Research & Development, LG Life Sciences, Ltd.) ;
Kim, Chan-Wha (Graduate School of Life Sciences and Biotechnology, Korea University)

Hong, C. Y. IL. FARMACO 2001, 56, 41 https://doi.org/10.1016/S0014-827X(01)01017-5
LG Life Science DMF Number 14524; FDA: Rockville, MD, USA, 1999
Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH, Federal Register; FDA: Rockville, MD, 2005
Shirota, O.; Ohtsu, Y.; Nakata, O. J. Chromatogr. Sci. 1990, 28, 553 https://doi.org/10.1093/chromsci/28.11.553
Kele, M.; Cuiochon, G. J. Chromatogr. 2000, 869, 181 https://doi.org/10.1016/S0021-9673(99)01092-4
Guideline for Industry, Q1A Stability Testing of New Drug Substances and Products, ICH, Federal Register; FDA: Rockville, MD, 1996
Reviewer Guidance, Validation of Chromatographic Methods; Center for Drug Evaluation and Research, FDA: Rockville, MD, 1994
Pathare, D. B.; Jadhav, A. S. J. Pharm. Biomed. Anal. 2006, 41, 1152 https://doi.org/10.1016/j.jpba.2006.02.024

Validated stability-indicating HPLC method for analysis of gemifloxacin in tablet formulations vol.23, pp.1, 2011, https://doi.org/10.1556/AChrom.23.2011.1.6