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

Autor: El-Gendy H; Pharmaceutical Chemistry Department, Faculty of Pharmacy, Misr International University, Km 28 Ismailia Road, Cairo, 44971, Egypt., Zarad W; Pharmaceutical Chemistry Department, Faculty of Pharmacy, Misr International University, Km 28 Ismailia Road, Cairo, 44971, Egypt., Bazan L; Pharmaceutics Department, Faculty of Pharmacy, Misr International University, Km 28 Ismailia Road, Cairo, 44971, Egypt., Ali A; Leiden Academic Centre for Drug Research (LACDR), Leiden University, Einsteinweg 55, 2333 CC, Netherlands; Research Center, Misr International University, Km 28 Ismailia Road, Cairo, 44971, Egypt., Aboulella Y; Leiden Academic Centre for Drug Research (LACDR), Leiden University, Einsteinweg 55, 2333 CC, Netherlands; Research Center, Misr International University, Km 28 Ismailia Road, Cairo, 44971, Egypt., Kamal M; Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Ahram Canadian University, 4th Industrial Zone, Banks Complex, 6th of October, Cairo, 12256, Egypt., Emara S; Pharmaceutical Chemistry Department, Faculty of Pharmacy, Misr International University, Km 28 Ismailia Road, Cairo, 44971, Egypt. Electronic address: emara_miu@yahoo.com., Shawky A; Pharmaceutical Chemistry Department, Faculty of Pharmacy, Misr International University, Km 28 Ismailia Road, Cairo, 44971, Egypt.
Jazyk: angličtina
Zdroj: Analytical biochemistry [Anal Biochem] 2022 Dec 15; Vol. 659, pp. 114951. Date of Electronic Publication: 2022 Oct 13.
DOI: 10.1016/j.ab.2022.114951
Abstrakt: A rapid back flushed (BF) direct sample injection (DSI) high-performance liquid chromatography (HPLC) with UV detection (BF-DSI-HPLC-UV) has been developed to determine terbinafine (TERB) in human serum. For online solid phase extraction step, an isocratic mobile phase of phosphate buffer saline (pH 7.4) at 1 mL/min and a short protein-coated ODS column (PC-ODS-column) were used for the purification and enrichment of TERB. Two different chromatographic modes of PC-ODS-column were simultaneously operated. Macromolecular proteins were extracted by size-exclusion liquid chromatography, while TERB trapping and enrichment were achieved through reversed-phase liquid chromatography. The clear fraction containing TERB was transferred from the PC-ODS-column by BF mode onto the quantification step through a high pressure switching valve. An analytical mobile phase consisting of 80% methanol and 1% triethylamine in distilled deionized water (pH) 6 at 1 mL/min was used for the final separation on an ODS analytical column. TERB was quantified and detected by UV-detector at 224 nm. The proposed method showed high correlation coefficient (>0.999) over the concentrations range 4-1600 ng/mL with recoveries ranging from 98.48 to 93.86%. Measurement of TERB concentration in serum after administration of a single dose of 250 mg oral tablet was used to evaluate the applicability of the BF-DSI-HPLC-UV for pharmacokinetic study.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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Databáze: MEDLINE