Quality Control of Drugs

Taha, Mohammed; Abed, A R Moghareh; Deeb, Sami El

doi:10.1002/9783527633241.ch10

Cited by 4 publications

(2 citation statements)

References 54 publications

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“…Thereby, the possible unwanted interaction between the chiral selectors is also hindered in contrast to mixing them and adding them as CMPA. The increase in analysis time due to column coupling and longer total columns length could be compensated by flow-programming [47]. Two dimensional (2D-HPLC) mostly of chiral achiral columns with or without a switching valve is showing good success in chiral separation [48,49].…”

Section: Monolithic Column Couplingmentioning

confidence: 99%

Chiral Monolithic Silica-Based HPLC Columns for Enantiomeric Separation and Determination: Functionalization of Chiral Selector and Recognition of Selector-Selectand Interaction

et al. 2021

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This review draws attention to the use of chiral monolithic silica HPLC columns for the enantiomeric separation and determination of chiral compounds. Properties and advantages of monolithic silica HPLC columns are also highlighted in comparison to conventional particle-packed, fused-core, and sub-2-µm HPLC columns. Nano-LC capillary monolithic silica columns as well as polymeric-based and hybrid-based monolithic columns are also demonstrated to show good enantioresolution abilities. Methods for introducing the chiral selector into the monolithic silica column in the form of mobile phase additive, by encapsulation and surface coating, or by covalent functionalization are described. The application of molecular modeling methods to elucidate the selector–selectand interaction is discussed. An application for enantiomeric impurity determination is also considered.

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Section: Monolithic Column Couplingmentioning

confidence: 99%

Chiral Monolithic Silica-Based HPLC Columns for Enantiomeric Separation and Determination: Functionalization of Chiral Selector and Recognition of Selector-Selectand Interaction

et al. 2021

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“…The first generation monolithic silica RP-18e columns have been successfully applied in method transfer from conventional particle packed columns or for the development of new fast methods (8)(9)(10)(11)(12)(13)(14)(15)(16)(17). Furthermore, application of the flow programming elution mode with monolithic silica RP-18e columns produced ultra-fast methods of just a few seconds with good precision (14,18,19).…”

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confidence: 99%

Comparing monolithic and fused core HPLC columns for fast chromatographic analysis of fat-soluble vitamins

et al. 2017

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HPLC stationary phases of monolithic and fused core type can be used to achieve fast chromatographic separation as an alternative to UPLC. In this study, monolithic and fused core stationary phases are compared for fast separation of four fat-soluble vitamins. Three new methods on the first and second generation monolithic silica RP-18e columns and a fused core pentafluoro-phenyl propyl column were developed. Application of three fused core columns offered comparable separations of retinyl palmitate, DL-α-tocopheryl acetate, cholecalciferol and menadione in terms of elution speed and separation efficiency. Separation was achieved in approx. 5 min with good resolution (R s > 5) and precision (RSD ≤ 0.6 %). Monolithic columns showed, however, a higher number of theoretical plates, better precision and lower column backpressure than the fused core column. The three developed methods were successfully applied to separate and quantitate fat-soluble vitamins in commercial products.Keywords: monolithic silica column, fused core column, HPLC, fat-soluble vitamins, analytical performance There is an increasing demand for fast chromatographic methods suitable for routine analyses with low analysis cost. So far, HPLC is the main instrumental technique used widely for the separation and quantification of drugs. Accordingly, there is an enormous need for highly efficient, selective LC columns to provide faster and more precise analyses, especially for high throughput samples in research laboratories and pharmaceutical industry. Three approaches are currently in competition to achieve fast chromatographic analysis UPLC (ultra performance liquid chromatography), fused core columns and monolithic columns, attached to HPLC (1, 2).UPLC relies on the use of short columns with sub-2-μm particles. The UPLC instrument is designed to resist pressure up to 1.5 × 10 8 Pa, which exceeds the pressure limits for SAID EL KURDI 1

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Development and validation of a LC method for the separation and determination of the anticancer-active Fe^III(4-methoxy-salophene) using the new second-generation monolith

2012

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LC method with the newly introduced second-generation monolithic silica RP-18e column has been developed for the separation of Fe(III) (salophene) and four methoxy-substituted Fe(III) (salophene) complexes. The method has been validated for the quantitation of Fe(III) (4-OMe-salophene), a highly active anticancer substance in vitro, bound to serum albumin. Our routinely used high-resolution continuum-source atomic absorption spectroscopy method based on the determination of the central iron atom was unsuitable in this case because serum originally contains significant amounts of iron as revealed by a blank sample of serum albumin. The developed LC method depends on detecting the whole complex rather than the bound iron. Two morphologically different first- and second-generation HPLC monolithic columns have been compared for this purpose. The newly introduced second-generation monolithic silica column Chromolith(®) HighResolution RP-18e column (100 × 4.6 mm, Merck) separated the mixture successful within 13 min. A mobile phase consisting of 25 mM phosphate buffer pH 3/methanol (60:40, v/v) was used at a flow rate of 1 mL/min. The dynamic linear working range of the calibration curve for Fe(III) (4-OMe-salophene) was found to be between 1 and 200 μg/mL. Detection and quantitation limits were 0.3 and 1 μg/mL, respectively.

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Quality Control of Drugs

Cited by 4 publications

References 54 publications

Chiral Monolithic Silica-Based HPLC Columns for Enantiomeric Separation and Determination: Functionalization of Chiral Selector and Recognition of Selector-Selectand Interaction

Chiral Monolithic Silica-Based HPLC Columns for Enantiomeric Separation and Determination: Functionalization of Chiral Selector and Recognition of Selector-Selectand Interaction

Comparing monolithic and fused core HPLC columns for fast chromatographic analysis of fat-soluble vitamins

Development and validation of a LC method for the separation and determination of the anticancer-active Fe^III(4-methoxy-salophene) using the new second-generation monolith

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Quality Control of Drugs

Cited by 4 publications

References 54 publications

Chiral Monolithic Silica-Based HPLC Columns for Enantiomeric Separation and Determination: Functionalization of Chiral Selector and Recognition of Selector-Selectand Interaction

Chiral Monolithic Silica-Based HPLC Columns for Enantiomeric Separation and Determination: Functionalization of Chiral Selector and Recognition of Selector-Selectand Interaction

Comparing monolithic and fused core HPLC columns for fast chromatographic analysis of fat-soluble vitamins

Development and validation of a LC method for the separation and determination of the anticancer-active FeIII(4-methoxy-salophene) using the new second-generation monolith

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Product

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Development and validation of a LC method for the separation and determination of the anticancer-active Fe^III(4-methoxy-salophene) using the new second-generation monolith