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.
Highlights
The inherent stability characteristics of a drug should be established using stress studies on the parent drug according to the stability test ICH guideline Q1A (R2) [1]
The results showed that gemifloxacin mesylate (GFX) was developed with methanol and ethyl acetate but with unsuitable Rf value
This work described simple, sensitive, and selective stability-indicating High performance thin-layer chromatography (HPTLC) assay with fluorescence detection for determination of GFX
Summary
The inherent stability characteristics of a drug should be established using stress studies on the parent drug according to the stability test ICH guideline Q1A (R2) [1]. High performance thin-layer chromatography (HPTLC) has been widely used in the pharmaceutical analysis as stability-indicating assay [2], and for clinical pharmacokinetic studies [3]. The analysis in these areas usually involves measurement of very low concentrations of drugs and/or degradation products which can be detected by HPTLC in nanogram and picogram levels in absorbance and fluorescence based measurements, respectively. The importance and widespread of HPTLC in pharmaceutical analysis are attributed to their inherent selectivity, high sensitivity, sustainability and low operating costs. Its use in the developing countries will greatly help them in identifying the counterfeit and sub-standard pharmaceutical products in their markets, where the WHO has identified this illegal distribution as a major problem in the developing countries [4]
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