Rapid back flushed direct sample injection bio-analytical HPLC-UV method for therapeutic drug monitoring of terbinafine

El-Gendy, Heba; Zarad, Walaa; Bazan, Lamyaa; Ali, Ahmed; Aboulella, Yasmine; Kamal, Maha; Emara, Samy; Shawky, Ahmed M.

doi:10.1016/j.ab.2022.114951

Cited by 3 publications

(2 citation statements)

References 26 publications

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“…Column switching serves a variety of purposes in online SPE and SPME strategies, which are widely used in many automated LC methods. Several successful online SPE approaches, followed by HPLC analysis with UV and FL detection systems using an isocratic elution mode, have been described [60,61]. These systems were designed with second pumps and six-port switching valves for better methods development.…”

Section: Column Switching and Large Volume Sample Injectionmentioning

confidence: 99%

“…It is desirable to develop an HPLC method that can directly analyze biological samples comprising proteins for the sake of simplicity and reproducibility of chromatographic analysis. As mentioned briefly in several research articles [60,61,[95][96][97][98][99][100], RP materials coated with denatured plasma proteins ("protein-coated (PC) columns") exhibited RP properties for hydrophobic small molecules even though they lost their affinity for plasma proteins. Protein immobilization integrates various chromatographic modes in packed porous particles (most commonly, a size exclusion mode caused by small pores as well as non-retentive outer layers with an RP mode of a retentive inner pore surface) to accommodate the matrix's macromolecular components extraction and analytes enrichment prior to HPLC separation methodologies.…”

Section: Immobilized Protein Reversed Phase Columns For Solid-phase E...mentioning

confidence: 99%

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Sensitivity Enhancement for Separation-Based Analytical Techniques Utilizing Solid-Phase Enrichment Approaches and Analyte Derivatization for Trace Analysis in Various Matrices

et al. 2023

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Despite the fact that strong routine separation methodologies can give reliable specificity and validity at usual working pharmaceutical concentrations, they may fail at very low concentration levels. This poses considerable challenges for researchers investigating product purity and therapeutic drug monitoring. Sensitivity enhancement procedures are thus required to maximize the performance of separation techniques. Solid-phase extraction/solid-phase enrichment (SPE/SPEn) and pre-, post-, and in-column derivatization, as well as the use of sensitive detection devices, are the simplest strategies for improving sensitivity of separation-based analytical techniques. Large-volume injection of samples with online SPE/SPEn coupled with separation techniques increased sensitivity and improved detection as well as quantification limits without affecting peak shape and system performance. Although the primary purpose of derivatization is to improve sensitivity and selectivity, greener derivatization is growing in popularity and should be considered in analytical chemistry. In general, two strategies are essential for accomplishing greener derivatization goals. The first is the search for and use of ecologically acceptable derivatizing reagents, solvents, and reaction conditions. The second is miniaturization and automation of analytical methods. This review discusses significant advances in separation-based analytical techniques, specifically enrichment approaches and detector signal improvement for pharmaceutical quantification in various matrices at very low concentration levels. As a result of improved analytical systems setup in drug assays, the possibility of high-throughput analyses was also highlighted.

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Section: Column Switching and Large Volume Sample Injectionmentioning

confidence: 99%

Section: Immobilized Protein Reversed Phase Columns For Solid-phase E...mentioning

confidence: 99%

Sensitivity Enhancement for Separation-Based Analytical Techniques Utilizing Solid-Phase Enrichment Approaches and Analyte Derivatization for Trace Analysis in Various Matrices

et al. 2023

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Overview of therapeutic drug monitoring and clinical practice

Fang

Guo

2024

Talanta

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Simple and Sensitive Spectrophotometric Assays for the Determination of Terbinafine HCL Antifungal Drug in Pharmaceuticals

Qarah,

El-maaıden,

Basavaiah

2024

Ankara Ecz. Fak. Derg.

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Objective: Two highly sensitive, accurate, inexpensive, and simple spectrophotometric assays were developed and validated for the determination of an anti-fungal drug, Terbinafine HCl (TBH), in pure drug and tablets using potassium permanganate (PP) and disodium 2-(1,3-dioxo-2,3-dihydro-1H-inden-2-yl)quinoline-6,8-disulfonate (DSOQ). Material and Method: In the present study, Sebifin and Terbiforce 250 mg tablets were used as pharmaceuticals, potassium permanganate KMnO4 and disodium 2-(1,3-dioxo-2,3-dihydro-1H-inden-2-yl)quinoline-6,8-disulfonate in water were used as reagents, and DR 3900 spectrophotometer equipped with 1cm matched quartz cells was used for absorbance measurements. Result and Discussion: The amount of terbinafine hydrochloride reacting with permanganate and disodium 2-(1,3-dioxo-2,3-dihydro-1H-inden-2-yl)quinoline-6,8-disulfonate in an acidic medium has been determined. The colored reaction products in both cases were measured at the maximum absorptions of 540 nm and 440 nm, respectively. The absorbance measured in each assay as a function of TBH concentration was related to TBH concentrations. Different experimental and variable conditions of assays were done carefully, accurately studied, and optimized. The validation of two assays also was done by following the current guidelines of the International Conference on Harmonization (ICH). Beer’s law for the two methods is obeyed over the concentration ranges 1-15 µg/ml (Correlation coefficient = 0.9983) and 1-18 µg/ml (Correlation coefficient = 0.9989) for methods PP and DSOQ, respectively. Molar absorptivity, limits of detection, and quantification (LOD & LOQ) values were (1.38×104 l/ mol cm, 0.92 & 2.78 µg/ml) for PP assay, and (1.73×104 l/ mol cm, 0.09 & 0.27 µg/ml) for DSOQ assay, respectively. The two assays were successfully applied for the determination of TBH in commercial tablets with reliable and satisfactory results, and hence the proposed assays can be applied in pharmaceutical laboratories of quality control.

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Rapid back flushed direct sample injection bio-analytical HPLC-UV method for therapeutic drug monitoring of terbinafine

Cited by 3 publications

References 26 publications

Sensitivity Enhancement for Separation-Based Analytical Techniques Utilizing Solid-Phase Enrichment Approaches and Analyte Derivatization for Trace Analysis in Various Matrices

Sensitivity Enhancement for Separation-Based Analytical Techniques Utilizing Solid-Phase Enrichment Approaches and Analyte Derivatization for Trace Analysis in Various Matrices

Overview of therapeutic drug monitoring and clinical practice

Simple and Sensitive Spectrophotometric Assays for the Determination of Terbinafine HCL Antifungal Drug in Pharmaceuticals

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