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

Abstract

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 C 18 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.

Simple Determination of Gemifloxacin Levels in Human Plasma using High-Performance Liquid Chromatography-Tandem Mass Spectrometry

“…Several analytical methods, in matrices such as plasma, serum, or whole blood, urine, or pharmaceutical formulations, for determining gemifoxacin concentrations have been reported and mainly include liquid chromatography with spectrophotometric detection (LC/UV) [19][20][21][22] or liquid chromatography methods with spectrofuorometric detection (LC/FD) [23,24]. Furthermore, capillary electrophoresis [17] and derivatization have been used in combination with spectrofuorometry [18].…”

“…Analytical methods for the determination of gemifoxacin concentrations include capillary electrophoresis [17], spectrofuorimetry [18], high-performance liquid chromatography (HPLC) [19][20][21][22][23][24], and high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) [25][26][27]. Among these, HPLC and LC-MS/MS are the preferred methods because of their inherent selectivity and high sensitivity.…”

“…Among these, HPLC and LC-MS/MS are the preferred methods because of their inherent selectivity and high sensitivity. However, only a few previously reported HPLC and LC-MS/MS methods can quantify gemifoxacin in biological fuids, such as urine and serum or plasma [22,[25][26][27]. Moreover, previous methods of HPLC and LC-MS/MS necessitated sophisticated conditions, such as specifc chromatographic columns [23] or elusive internal standards such as isotope-labeled gemifoxacin [25].…”

“…Moreover, previous methods of HPLC and LC-MS/MS necessitated sophisticated conditions, such as specifc chromatographic columns [23] or elusive internal standards such as isotope-labeled gemifoxacin [25]. Te major drawbacks include the tedious, timeconsumingsample-preparation procedures, such as derivatization [18,24] or extraction [18,26] after the drying of the fnal extract and the reconstitution steps [22]. Tese methods not only necessitate lengthy sample-preparation procedures but also require longer chromatographic run times (≥4 minutes) [19, 20, 22-24, 26, 27].…”