Comparison between core–shell and totally porous particle stationary phases for fast and green LC determination of five hepatitis‐C antiviral drugs

Abstract

The performances of core-shell 2.7 μm and fully porous sub-2 μm particles packed in narrow diameter columns were compared under the same chromatographic conditions. The stationary phases were compared for fast separation and determination of five new antiviral drugs; daclatasvir, sofosbuvir, velpatasvir, simeprevir, and ledipasvir. The gradient elution was done using ethanol as green organic modifier, which is more environmentally friendly. Although both columns provided very good resolution of the five drugs, core-shell particles had proven to be of better efficiency. Under gradient elution conditions, core-shell particles exhibited faster elution, better peak shape, and enhanced resolution adding to lower system backpressure. The column backpressure on sub-2 μm particles was more than twice that on core-shell particles. This gives a chance to use conventional high-performance liquid chromatography conditions without needing special instrumentation as that required for ultra-high performance liquid chromatography. The method was validated for determination of the five drugs by gradient elution using mobile phase composed of organic modifier ethanol and aqueous part containing 0.75 g sodium octane sufonate and 3.0 g sodium dihydrogen phosphate per liter at pH of 6.15. Detection was done using UV-detector set at 210 nm. The linearity, accuracy, and precision were found very good within the concentration range of 2-200 μg/mL.

Development and validation of eco-friendly micellar-HPLC and HPTLC-densitometry methods for the simultaneous determination of paritaprevir, ritonavir and ombitasvir in pharmaceutical dosage forms

“…When we compare the proposed HPLC method to other reported methods; UHPLC methods [10, 11] have lower solvents and energy consumptions than the conventional HPLC methodologies. However, UHPLC methods have higher maintenance costs due to the shorter column life-time and requirement of special instrumentation especially those coupled with MS-MS detectors [13]. That's why UHPLC use in economic establishments like pharmaceutical quality control laboratories is limited and not widespread.…”

“…That's why ongoing greener in chromatography we have to develop new methodologies that minimize solvents consumption and replace the ecologically dangerous ones [15]. ACN is a hazardous solvent listed in the US Environmental protection Agency of toxic chemicals, January-2019 [16], however, EtOH is a biodegradable and cheap solvent with low volatility characteristics which renders the mobile phase composition more stable upon longer storage [13]. All other reported HPLC methods utilize ACN and MeOH in the mobile phase which are both listed in the US Environmental protection Agency of toxic chemicals, January-2019 [16] which was replaced in the proposed method by the safer solvent; EtOH,.…”

Development of a highly sensitive high‐performance thin‐layer chromatography method for the screening and simultaneous determination of sofosbuvir, daclatasvir, and ledipasvir in their pure forms and their different pharmaceutical formulations

“…SFS is a pan‐genotypic inhibitor of HCVNS5B RNA‐dependent RNA polymerase, which is essential for viral replication, SFS is nucleotide prodrug which is converted to active uridine analog triphosphate (GS 461203) by intracellular metabolism . Different analytical methods were reported for determination of SFS including spectrophotometry , HPLC–UV , HPLC–MS , UHPLC–MS/MS , and high‐performance thin layer chromatography (HPTLC) . Daclatasvir (DAC), Figure , is chemically methyl [(2 S )‐1‐{3‐[5‐{4′‐[2‐{1‐[(methoxycarbonyl)‐ l ‐valyl]pyrrolidin‐2‐yl}‐1 H ‐imidazol‐5‐yl]‐(1,1′‐biphenyl)‐4‐yl}‐1 H ‐imidazol‐2‐yl]pyrrolidin‐1‐yl}‐3‐methyl‐1‐oxobutan‐2‐yl]carbamate.…”

“…LDS is direct‐acting antiviral drug which has a mechanism of action similar to that of DAC. Different analytical methods were proposed for the determination of LDS withers alone or in combination with SFS, including spectrophotometry , HPLC–UV , HPLC–MS , UHPLC–MS/MS , and HPTLC . HPTLC as a technique of analysis was used for the separation of different pharmaceutical mixtures , and stability indicating methods .…”

Nonlinear model of liquid chromatography considering finite rates of adsorption-desorption kinetics and core-shell adsorbents

“…[18] Ibrahim et al have compared core-shell and totally porous particle stationary phases for fast and green LC determination of five hepatitis-C antiviral drugs. [19] Theoretical aspects and technical properties of the columns packed with core-shell particles are described deeply in serval reviews. [20][21][22][23] In our recent article, we have numerically investigated elution profiles using core-shell particles under overloaded nonlinear conditions using a reduced GRM considering infinitely fast rates of adsorption and desorption, i.e.…”