TITLE:
Development and Validation of Stability Indicating HPTLC Assay for Determination of Gemifloxacin Mesylate in Dosage Forms
AUTHORS:
Ashraf M. Mahmoud, Noha N. Atia, Salwa R. El-Shabouri, Wesam M. El-Koussi
KEYWORDS:
HPTLC, Gemifloxacin Mesylate, Stability Indicating Assay, Kinetics, Degradation, Pharmaceutical Preparations
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.6 No.2,
January
16,
2015
ABSTRACT: Simple and
sensitive stability-indicating high performance thin layer chromatography
(HPTLC) assay was developed and validated for quantitative determination of the
antibacterial drug, gemifloxacin mesylate (GFX) in presence of its degradation
products and ambroxol hydrochloride. The chromatographic separation was performed
on HPTLC precoated silica gel plate 60F254 as stationary phase. The
mobile phase consisted of a mixture of ethyl acetate: methanol: 25% ammonia,
(8:4.5:3, v/v/v). The detection was performed using fluorescence mode and the
emission intensity was measured using optical filter K400 after excitation at
342 nm. The Rf value for GFX was 0.47 ± 0.03. Good correlation
coefficient was obtained over the concentration range of 1.5 - 180 ng/band. The
LOD and LOQ of the proposed method were 0.28 and 0.86 ng/band, respectively.
The proposed method was successfully applied for the analysis of GFX in its
single and combined dosage forms. Moreover, it was utilized to investigate the
kinetics of acidic, alkaline, neutral, oxidative and photolytic degradation of
the drug. The apparent kinetic-order rate constants and half-life times of the
degradation process were calculated. Furthermore, the proposed method was successfully
applied for investigating the factors affecting the storage of GFX.