Simple and Accurate HPTLC-Densitometric Method for Quantification of Delafloxacin (A Novel Fluoroquinolone Antibiotic) in Plasma Samples: Application to Pharmacokinetic Study in Rats

Abstract

Delafloxacin (DLX) is a recently-approved fluoroquinolone antibiotic, which is recommended for the treatment of “acute bacterial skin and skin structure infections”. A thorough literature survey revealed only a single published method for the estimation of DLX using UPLC-MS/MS technique in biological samples. There is no high-performance thin-layer chromatography (HPTLC) method has been reported for the estimation of DLX in dosage forms and/or biological samples. Therefore, a selective, sensitive, rapid and validated HPTLC-densitometry technique has been used for the estimation of DLX in human plasma for the first time. HPTLC quantification of DLX and internal standard (IS; gatifloxacin) was carried out on glass coated silica gel 60 F254 HPTLC plates using the ternary mixture of ethyl acetate:methanol:ammonia solution 5:4:2 (%, v/v/v) as the mobile phase. Densitometric detection was done at 344 nm. The Rf values were recorded as 0.43 and 0.27 for the DLX and the IS, respectively. The linearity range of DLX was obtained as 16–400 ng/band. A simple protein precipitation method was used for the extraction of analyte from plasma using methanol. The proposed HPTLC technique was validated for “linearity, accuracy, precision, and robustness”. The proposed HPTLC technique was successfully utilized for the assessment of pharmacokinetic profile of DLX in rats after oral administration. After oral administration, the peak plasma concentration of DLX was obtained as 194.19 ng/ml in 1 h. The proposed HPTLC method could be applied in study of pharmacokinetic profile and therapeutic drug monitoring of DLX in clinical practice.

Determination of Delafloxacin in Pharmaceutical Formulations Using a Green RP-HPTLC and NP-HPTLC Methods: A Comparative Study

“…However, the cost and maintenance of more robust and reliable apparatus such as "UHPLC-MS/MS" apparatus is very high compared with "high-performance thin layer chromatography (HPTLC)". Moreover, highly-skilled trained personnel are required to operate "UHPLC-MS/MS" apparatus compared with HPTLC [10,12]. Recently, a HPTLC method has been reported for the estimation of DLFX in human plasma and its pharmacokinetic assessment in real plasma samples of rats [12].…”

“…Moreover, highly-skilled trained personnel are required to operate "UHPLC-MS/MS" apparatus compared with HPTLC [10,12]. Recently, a HPTLC method has been reported for the estimation of DLFX in human plasma and its pharmacokinetic assessment in real plasma samples of rats [12]. Although, the reported HPTLC method was validated for the estimation of DLFX in biological samples, it was not applied to real pharmaceutical formulation samples [12].…”

“…Recently, a HPTLC method has been reported for the estimation of DLFX in human plasma and its pharmacokinetic assessment in real plasma samples of rats [12]. Although, the reported HPTLC method was validated for the estimation of DLFX in biological samples, it was not applied to real pharmaceutical formulation samples [12]. Some clinical reports are also available for the assessment of pharmacokinetic profile of DLFX in healthy human subjects and diseased patients but these clinical reports have not disclosed any information about method development and validation [13][14][15].…”

Quantitative determination of canagliflozin in human plasma samples using a validated HPTLC method and its application to a pharmacokinetic study in rats

“…In addition, the cost of the LC–MS/MS instrument is high and maintenance requires highly skilled technical expertise; therefore LC–MS/MS is not commonly accessible in laboratories. Hence in a resource‐limited setting, an economical and convenient method is usually preferred, provided its lower limit of quantitation (LLOQ) is sufficient for routine analysis (Alam, Iqbal, et al, 2020). With the advancements in stationary phases and the introduction of densitometers as detection equipment, high‐performance thin‐layer chromatography (HPTLC) technique achieves precision and accuracy for the estimation of drugs compared with HPLC (Alam, Ezzeldin, et al, 2020; Bhatt, Chavada, Sanyal, & Shrivastav, 2019; El‐Yazbi, Amin, El‐Kimary, Khamis, & Younis, 2018).…”

Quantitative Analysis of Emtricitabine in Dosage Forms Using Green RP-HPTLC and Routine NP-HPTLC Methods—A Contrast of Validation Parameters

“… 29 − 34 Recently, researchers are focusing much attention on green HPTLC methods for the quantitative analysis of drugs/pharmaceuticals in dosage forms and biological samples. 35 − 38 In addition, green HPTLC methods present many advantages compared to routine HPTLC methods of analysis. 39 − 41 In RP-HPTLC analysis, the acetone/water solvent system was used.…”