Method Development and Validation of Gemifloxacin by using Gas Chromatography

K. Padmalatha, Vijaya Durga. D*, Sk. Salma, N. Naga Lakshmi, Ch. Janaki, U. Sony, M. Shireen, K.V.S.S. Sahithi
Department of Pharmacology, Vijaya Institute of Pharmaceutical Sciences for Women, Enikepadu, Vijayawada-521108, India.

ABSTRACT
The aim of present research work to development of simple, rapid and cost-effective method for the estimation Gemifloxacin by using gas chromatography with flame ionization detector (GC-FID).The solutions of standard and the sample were prepared in DMSO and Dichloromethane and Isopropyl were used as residual solvents.  GC separation was performed by 30m x 0.53mm ID fused silica coated with 6% cyanopropyl 94% dimethylpolysiloxane (DB 624 of SGE make is suitable).Nitrogen was used as carrier gas at a flow-rate of 4.18 ml/min. After injection of the sample at inlet temperature 1250o c, the temperature of the GC oven was as follows: initial temperature was 40oc, held for 5 min, increased to 125oC at a rate of 8oc min-1 held for 5 min, and finally to 225oc at a rate of 14oc min-1 and held for 10 min.  Detector temperature is 250oc. 1.5 µl was injected in split less mode. Calibration curves were linear between the concentration range 2.5-1.5µg ml-1. The method was validated for specificity, linearity, precision, accuracy and limit of quantitation. Also, the method was applied to directly and easily to the analysis of the pharmaceutical preparation of Gemifloxacin tablet.
Keywords: Gemifloxacin, Gas chromatography, DMSO, Pharmaceutical preparation