Development and Validation of Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Trifluridine and Tipiracilin Bulk and their Combined Dosage form

Mastanamma, Sk.; Nagaraju, K.; Reehana, S K.; Radhakrishnaveni, V.

doi:10.20902/ijctr.2019.120416

Cited by 4 publications

(4 citation statements)

References 2 publications

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“…The separation process hinges on the interaction between mobile phase and stationary phase, the fundamental elements of HPLC, possessing contrasting polarities and equipped with high-pressure pumps. Different HPLC methods have been documented for the quantification of RDV, SMV, and SFS, are shown in Table 3 [21][22][23][24][25][26][27][28][29][30][31]. These methods offer varied approaches to determine these compounds accurately.…”

Section: High-performance Liquid-chromatography (Hplc) Methodsmentioning

confidence: 99%

Analytical Profile of Antiviral Drugs-Remdesivir, Simeprevir, and Sofosbuvir: A Review

Eswarudu,

Krishna,

Babu

et al. 2024

UPJOZ

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Remdesivir (RDV) is an antiviral drug and a phosphonamidite prodrug designed to have activity against a broad spectrum of viruses, act as a nucleoside analogue, and inhibit the RNA-dependent RNA polymerase [RDRP] of coronaviruses, including SARS-CoV-2, whereas Simeprevir (SMV) and Sofosbuvir (SFS) are direct-acting antiviral drugs approved for the treatment of chronic Hepatitis C virus (HCV) infection. Reports show that the structure and replication mechanism of HCV and SARS-COV-2 are comparable. Hepatitis C virus protease inhibitors include Simeprevir. Because it is an NS3/4A protease inhibitor, it inhibits protein synthesis, which stops viruses from maturing. A nucleotide analogue inhibitor called sofosbuvir selectively blocks the RNA-dependent RNA polymerase of HCV NS5B (non-structural protein 5B). This review article gathers and discusses the range of analytical techniques—UV, HPLC, and hyphenated procedures like LC-MS—that are available in the literature for the determination of RDV, SMV, and SFS. This review article can be effectively explored to conduct future analytical investigation for the estimation of the selected drugs in pharmaceutical and biological samples.

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Section: High-performance Liquid-chromatography (Hplc) Methodsmentioning

confidence: 99%

Analytical Profile of Antiviral Drugs-Remdesivir, Simeprevir, and Sofosbuvir: A Review

Eswarudu,

Krishna,

Babu

et al. 2024

UPJOZ

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“…Moreover, the published assay [19] using larger plasma volume (500 µL), longer analytical run time (8 min), and the LLOQ was much higher, which significantly decrease the efficiency of simultaneous determination of these anti-colorectal cancer drugs in biological fluids. Furthermore, RP-HPLC methods with UV detection were developed to determine FTD and TIP in tablets, capsules, and bulk form [11][12][13][14][15][16][17][18]. However, these published methods adopted time-consuming and linear over range 2.5-15 µg/mL and are not applicable in biological samples or applied to a pharmacokinetic study.…”

Section: Comparison With Previous Methodologiesmentioning

confidence: 99%

“…Only a limited number of analytical approaches have been documented for the quantification of FTD and TIP. RP-HPLC techniques with UV detection were developed to quantify FTD and TIP in capsules, tablets, and bulk form [11][12][13][14][15][16][17][18]. Nevertheless, the methods that were reported utilized a linear range of 2.5-15 µg/mL and were also time-consuming.…”

Section: Introductionmentioning

confidence: 99%

Applicable Pharmacokinetic Study: Development and Validation of Bioanalytical LC-MS/MS Method for Simultaneous Determination of Tipiracil, Trifluridine and Its Two Metabolites 5-Trifluoromethyluracil, 5-Carboxy 2′-Deoxyuridine in Rat Plasma

El-Gendy,

Hefnawy,

Alzamil

et al. 2023

Separations

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A novel liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the simultaneous determination of tipiracil (TIP), trifluridine (FTD), and their metabolites, 5-trifluoromethyluracil (FTY) and 5-carboxy-2′-deoxyuridine (5CDU), in rat plasma. This method is highly sensitive, specific, and fast. Paracetamol (PAR) is used as an internal standard (IS). Using acetonitrile-induced protein precipitation, the analytes were extracted from a plasma sample and separated on a Waters BEH C18 (1.7 μm particle size, 50 mm × 2.1 mm ID) column protected by a security guard cartridge (C18, 4 × 2.0 mm). The isocratic mobile phase was made up of methanol and water containing 0.1% formic acid (80:20, v/v) at a flow rate of 0.5 mL/min for 4 min. The quantification was performed using a positive electrospray ionization (ESI) interface and a multiple-reaction monitoring (MRM) mode. The MRM transitions employed were m/z 242.96 → 182.88 for TIP, 296.96 → 116.86 for FTD, 180.98 → 139.85 for FTY, 272.96 → 156.86 for 5CDU, and 151.97 → 92.68 for IS. The validated method complied with the guidelines set by the US-FDA over on a linear concentration range of 5–4000 ng/mL for FTD, FTY, and 5CDU, and 5–1000 ng/mL for TIP. The coefficient of determination (r2) was equal to or greater than 0.997. The corresponding lower limits of detection (LLOD) were 1.5 ng/mL for FTD, FTY, and 5CDU and 1.0 ng/mL for TIP. The recoveries of all analytes from rat plasma ranged from 88.67% to 112.18%, and the mean relative standard deviation (RSD) of accuracy and precision result was less than or equal to 6.84%. FTD, FTY, 5CDU, and TIP demonstrated adequate stability throughout the various circumstances examined. Additionally, no matrix effects were identified for any of the analytes. The assay was effectively utilized to conduct a pharmacokinetic study in rats following the oral administration of FTD and TIP at a dosage of 5.6 mg/kg, with a ratio of 1:0.5 for FTD and TIP, respectively. This indicates that the suggested approach is suitable for future clinical research. The pharmacokinetic parameters Cmax (maximum concentration), Tmax (time to reach maximum concentration), t1/2 (half-life), AUC0-24 (area under the concentration–time curve from 0 to 24 h), AUC total (total area under the concentration–time curve), Ke (elimination rate constant), Vd (volume of distribution), and CL (clearance) of all analytes were assessed. The assay developed exhibits significant advancements compared to earlier bioanalytical methods documented in the literature. These improvements include high sensitivity, specificity, and efficacy in high throughput analysis of complex matrices. Additionally, the assay offers a shorter run time and smaller sample volume (50 μL).

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“…The literature review discloses that very few LC-MS/MS 11 and high-performance liquid chromatographic [12][13][14][15][16] techniques have been reported for the estimation of tipiracil and trifluridine. Based on the reported HPLC methods, there is a need to develop a rapid, sensitive reversed-phase UPLC method for simultaneous estimation of tipiracil and trifluridine in bulk and formulations.…”

Section: Fig 1: Structures Of A) Tipiracil and B) Trifluridinementioning

confidence: 99%

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2021

IJPSR

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Development and Validation of Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Trifluridine and Tipiracilin Bulk and their Combined Dosage form

Cited by 4 publications

References 2 publications

Analytical Profile of Antiviral Drugs-Remdesivir, Simeprevir, and Sofosbuvir: A Review

Analytical Profile of Antiviral Drugs-Remdesivir, Simeprevir, and Sofosbuvir: A Review

Applicable Pharmacokinetic Study: Development and Validation of Bioanalytical LC-MS/MS Method for Simultaneous Determination of Tipiracil, Trifluridine and Its Two Metabolites 5-Trifluoromethyluracil, 5-Carboxy 2′-Deoxyuridine in Rat Plasma

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