Abstract

In the present study two different RSLC columns, Acclaim RSLC 120 C18, 5.0 µm, 4.6 × 150 mm (column A) and Acclaim RSLC 120 C18, 2.2 µm, 2.1 × 100 mm (Column B) were utilized for the analysis of velpatasvir (VPS) in presence of sofosbuvir (SFV), where due to the encountered fluorescent properties of VPS fluorescent detection at 405 nm after excitation at 340 nm (Method 1) was used for its detection where the non-fluorescent SFV did not interfere. The same columns were further utilized for the simultaneous determination of SFV and VPS either in bulk form or in their combined tablet, where UV- spectrophotometric detection at 260 nm was selected for the simultaneous analysis of both drugs (Method 2). A mobile phase consisting of NaH2PO4, pH 2.5 (with phosphoric acid) and acetonitrile in a ratio of 60:40 v/v was used for both methods. The mobile phase was pumped at a flow rate of 1.0 mL/min when using column, A and 0.5 mL/min when using column B. The methods showed good linearity over the concentration ranges of 1.0–5.0 and 2.5–10.0 ng/mL for VPS when utilizing Method 1 A and B respectively. Where the linearity concentration range was from 30.0–150.0 to 120–600.0 ng/mL for VPS and SFV respectively when applying Method 2. Both methods 1 and 2 were performed by utilizing the two analytical columns. The different chromatographic parameters as retention time, resolution, number of theoretical plates (N), capacity factor, tailing factor and selectivity were carefully optimized. The results show that comparing the performance of the two utilized columns revealed that shorter column (2.1 mm × 100 mm) with small particle packing was superior to the longer column (4.6 × 150 mm) for the analysis of the studied drugs allowing a reduction of the analysis time by 70% without any detrimental effect on performance. This prompts the decrease of the investigation costs by saving money on organic solvents and expanding the overall number of analyses per day.

Highlights

  • Hepatitis C is an infectious liver disease caused by infection with Hepatitis C Virus (HCV) that is considered a very dangerous disease, influencing about from three to five million people in the United States (US) and aboutMoustapha et al BMC Chemistry (2019) 13:118 naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl]3-methyl-1-oxobutan-2-yl}carbamate, Fig. 1a.VPS is a Direct-Acting Antiviral (DAA) medication that plays a significant role in the combination therapy of chronic Hepatitis C

  • HCV is a solitary stranded RNA virus with nine particular genotypes, where, genotype 1 is the most widely recognized type in the United States, and influencing more than 70% of patients suffering from chronic HCV

  • SFV is a prodrug that is mainly used for the treatment of HCV, either alone or in combination with other drugs like, VPS, ribavirin, and ledipasvir [3] (Fig. 1b)

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Summary

Introduction

Hepatitis C is an infectious liver disease caused by infection with Hepatitis C Virus (HCV) that is considered a very dangerous disease, influencing about from three to five million people in the United States (US) and about. VPS is a Direct-Acting Antiviral (DAA) medication that plays a significant role in the combination therapy of chronic Hepatitis C. One of the major advantage of VPS is that it has a noteworthy raised boundary to resistance than its previous generation of NS5A inhibitors, as daclatasvir and ledipasvir, this accounts for its high potency and efficacy as a treatment for chronic Hepatitis C [2]. SFV is a prodrug that is mainly used for the treatment of HCV, either alone or in combination with other drugs like, VPS, ribavirin, and ledipasvir [3] (Fig. 1b)

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