Abstract
In this work; delafloxacin (DLFX) was determined using a validated green RP-HPTLC and NP-HPTLC methods in commercial tablets and in-house developed solid lipid nanoparticles (SLNs). RP-HPTLC determination of DLFX was performed using “RP-18 silica gel 60 F254S HPTLC plates”. However; NP-HPTLC estimation of DLFX was performed using “silica gel 60 F254S HPTLC plates”. For a green RP-HPTLC method; the ternary combination of ethanol:water:ammonia solution (5:4:2 v/v/v) was used as green mobile phase. However; for NP-HPTLC method; the ternary mixture of ethyl acetate: methanol: ammonia solution (5:4:2 v/v/v) was used as normal mobile phase. The analysis of DLFX was conducted in absorbance/reflectance mode of densitometry at λmax = 295 nm for both methods. RP-HPTLC method was found more accurate, precise, robust and sensitive for the analysis of DLFX compared with the NP-HPTLC method. The % assay of DLFX in commercial tablets and in-house developed SLNs was determined as 98.2 and 101.0%, respectively, using the green RP-HPTLC technique, however; the % assay of DLFX in commercial tablets and in-house developed SLNs was found to be 94.4 and 95.0%, respectively, using the NP-HPTLC method. Overall, the green RP-HPTLC method was found superior over the NP-HPTLC. Therefore, the proposed green RP-HPTLC method can be successfully applied for analysis of DLFX in commercial tablets, SLNs and other formulations containing DLFX.
Highlights
Delafloxacin (DLFX) is a novel fluoroquinolone antibiotic which was approved by the US FDA in 2017 [1,2] for the treatment of “acute bacterial skin and skin structure infections (ABSSSIs)” [3,4].It has been found effective for the treatment of community-acquired respiratory tract infectionsAntibiotics 2020, 9, 359; doi:10.3390/antibiotics9060359 www.mdpi.com/journal/antibiotics (CARTIs) [4,5]
These results indicated that the stearic acid (SA)-CS-solid lipid nanoparticles (SLNs) of DLFX was well prepared in the laboratory
A green RP-high-performance thin layer chromatography (HPTLC) method was developed and validated for the determination of DLFX in pure form, commercial tablets and in-house developed SLNs compared with a NP-HPTLC method
Summary
Delafloxacin (DLFX) is a novel fluoroquinolone antibiotic which was approved by the US FDA in 2017 [1,2] for the treatment of “acute bacterial skin and skin structure infections (ABSSSIs)” [3,4]. It is under clinical trial for CARTIs treatment [5] It has been reported active against major microbes responsible for ABSSSIs and CARTIs [6,7]. The reported HPTLC method was validated for the estimation of DLFX in biological samples, it was not applied to real pharmaceutical formulation samples [12]. Have increased significantly [18,19,20,21,22] In spite of their various beneficial characteristics, including “non-toxicity, non-volatility, non-inflammability, non-aggressiveness, high biodegradability and cost effectiveness”, the full potential of green solvents had not been utilized fully as the mobile phase for HPTLC estimation of drugs/pharmaceuticals [23,24,25]. Both green RP-HPTLC and NP-HPTLC methods were validated in terms of linearity, accuracy, precision, robustness and sensitivity according to the “International Conference on Harmonization (ICH)” Q2 (R1) guidelines [31]
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