title: Chromatographic Analysis of a Multicomponent Mixture of B1, B6, B12, Benfotiamine, and Diclofenac; Part I: HPLC and UPLC Methods for the Simultaneous Quantification of These Five Components in Tablets and Capsules.
abstract: New, simple, highly sensitive, precise, and accurate gradient reversed-phase chromatographic methods were developed using HPLC and ultra-HPLC (UPLC) systems for the determination of five components, namely thiamine, pyridoxine, cyanocobalamin, benfotiamine, and diclofenac in tablets and capsules. The methods were compared for their efficiency in the separation and determination of these five compounds using two different C18 columns (250 × 4.6 mm, 5 μm; and 100 × 4.6 mm, 2.6 μm) for HPLC and UPLC, respectively. Chromatographic separation was performed with a mobile phase containing acetonitrile and 0.025 M phosphate buffer (pH 3.5), with a gradient program and a flow rate of 1.5 and 1.0 mL/min for both methods, respectively. The methods were validated according to International Conference on Harmonization guidelines. Linearity was achieved in the range of 5.00 to 150.00 μg/mL for each of the five compounds. Ruggedness and intermediate precision were confirmed by different analysts on different columns on different days. Moreover, the components were subjected to an accelerated stability study under acidic, alkaline, and oxidative stress conditions and no interfering peaks were observed. The five compounds were efficiently separated in <20 min by HPLC, whereas for UPLC, separation was achieved in <8 min, which dramatically decreased the consumption of organic solvents.
authors.affiliation: Cairo University Faculty of Pharmacy, Analytical Chemistry Department, Kasr El-Aini Street, Cairo, Egypt 11562.
authors.forename: Ahmed Salah
authors.initials: AS
authors.lastname: Fayed
authors.affiliation: Cairo University Faculty of Pharmacy, Analytical Chemistry Department, Kasr El-Aini Street, Cairo, Egypt 11562.
authors.forename: Maha Abdel-Monem
authors.initials: MA
authors.lastname: Hegazy
authors.affiliation: Beni Suef University, Faculty of Pharmacy, Analytical Chemistry Department, Alshahed Shehata Ahmed Hegazy St, Beni Suef, Egypt 62514.
authors.forename: Nada Sayed Abdel
authors.initials: NS
authors.lastname: Wahab
mesh_terms: D002214:Capsules / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D004008:Diclofenac / Q000032:analysis* / Q000737:chemistry; D013607:Tablets / Q000737:chemistry; D013831:Thiamine / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry; D014803:Vitamin B Complex / Q000032:analysis* / Q000737:chemistry
chemical_list: D002214:Capsules; D013607:Tablets; D014803:Vitamin B Complex; D004008:Diclofenac; D013831:Thiamine; C013835:benphothiamine