A Validated Reverse Phase-Ultra-Performance Liquid Chromatography Method for the Determination of Gemifloxacin Mesylate in Bulk and its Pharmaceutical Preparation.

OBJECTIVES: Gemifloxacin Mesylate is a fourth generation fluoroquinolone antibacterial agent. A simple, accurate, and precise reversed phase (RP)-ultra performance liquid chromatography (UPLC) method was developed and validated for short time analysis of Gemifloxacin Mesylate in its bulk and pharmaceutical preparation.
MATERIALS AND METHODS: The optimum separation was achieved at 0.5±0.03 min using an AcclaimTM RSLC 120 C18 column 2.2 μm (2.1×100 mm) at 30°C by isocratic mobile phase at pH 3.0 composed of acetonitrile:phosphate buffer (25 mM) in a ratio of 75:25 (v/v). The column effluents were monitored at 276 nm using a photodiode array detector at a flow rate of 0.5 mL/min. The method was validated according to International Conference on Harmonization guidelines.
RESULTS: The linearity of the calibration curve ranged from 0.5 μg/mL to 10 μg/mL and the square of the regression coefficient (r2) was 0.9991. The % relative standard deviation (RSD) of inter-day precision ranged from 0.081% to 1.233%, while for intra-day it ranged from 0.364% to 1.018%. The method was accurate with % recovery ranging from 93.71% to 100.29% and % RSD ranging from 1.054 to 2.722. The limit of detection and the limit of quantification were 0.066 and 0.2 μg/mL, respectively.
CONCLUSION: The validated method proved its ability for the assay of Gemifloxacin Mesylate in its bulk and dosage form in a short time (less than 1 min). To the best of our knowledge, this is the first RP-UPLC method for the determination of Gemifloxacin Mesylate. ©Copyright 2019 Turk J Pharm Sci, Published by Galenos Publishing House.