Stability indicating RP-HPLC technique for simultaneous estimation of nirmatrelvir and ritonavir in their new copackaged dosage form for COVID-19 treatment

Scientific Reports, Год журнала: 2025, Номер 15(1)

Опубликована: Янв. 17, 2025

RP-HPLC technique was developed and optimized for simultaneous identification estimation of nirmatrelvir (NIR) ritonavir (RIT) in their new copackaged tablet. Stability studied after exposure to different five stress conditions; alkali, acid, heat, photo oxidation degradation. The chromatographic separation achieved using VDSpher PUR 100 ODS (4.6-mm x 15-mm), 3.5 μm column mixture 0.03 M potassium di-hydrogen phosphate buffer pH 4 acetonitrile (45:55, v/v) as mobile phase. temperature set at 40 °C, flow rate 1mL/min UV detection 215 nm. NIR RIT retention times were 3.94 ± 0.08 min 9.08 0.1 min, respectively. Linear relationship established range (1.5-105 µg/mL) (1-70 with good reproducibility. found mean percentage recoveries 100.03% 99.85%, method shows very sensitivity the LOQ LOD be 3.001 & 0.990 µg/mL, respectively 2.765 0.912 RIT. approach validated concerning ICH guidelines applied successfully dosage from. results assay proposed compared statistically by applying published one agreement.

Язык: Английский

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Real-world Plasma Exposure of Nirmatrelvir/Ritonavir in Chinese Hospitalized Patients With COVID-19: A Multicenter Retrospective Study

Therapeutic Drug Monitoring, Год журнала: 2025, Номер unknown

Опубликована: Янв. 30, 2025

Nirmatrelvir/ritonavir is licensed for the treatment of mild-to-moderate coronavirus disease (COVID-19) in patients at an increased risk progression to severe disease. However, data on real-world plasma exposure nirmatrelvir/ritonavir remain limited, particularly Chinese patients. This study aimed assess trough concentration (Ctrough) and identify its critical factors hospitalized treated with 300 mg/100 mg twice daily over a 5-day course. A high-performance liquid chromatography-tandem mass spectrometry assay was developed validated measure Ctrough. Correlation analyses were performed variables influencing Among 110 patients, 100% had concentrations above antiviral vitro 90% effective concentration. The median Ctrough nirmatrelvir 4.55 mcg/mL (15.6× concentration), ranging from 0.65 12.44 mcg/mL. Nirmatrelvir normal mild renal impairment cohorts comparable (4.09 ± 1.97 4.57 2.21 mcg/mL) but significantly moderate cohort (6.41 2.31 mcg/mL). Sex, age, obesity not associated exposure. high COVID-19, therapeutic drug monitoring should be routinely recommended, except impairment.

Язык: Английский

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Comparison of greenness and blueness assessments for analytical methods used in the analysis of ritonavir, favipiravir, and molnupiravir: Applications in different matrices

Microchemical Journal, Год журнала: 2025, Номер unknown, С. 113165 - 113165

Опубликована: Фев. 1, 2025

Язык: Английский

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Homogeneous liquid–liquid microextraction coupled with HPLC/DAD for determination of nirmatrelvir and ritonavir as COVID-19 combination therapy in human plasma

BMC Chemistry, Год журнала: 2023, Номер 17(1)

Опубликована: Ноя. 24, 2023

Abstract The study reports the development of a high-performance liquid chromatography/diode array detection method to measure levels nirmatrelvir and ritonavir in human plasma. These two antiviral medications are used for treatment COVID-19 marketed as Paxlovid ® . employed sugaring-out induced homogeneous liquid–liquid microextraction improve sensitivity. Optimization was performed using one variable at time approach by adjusting several factors such type sugar, extractant, amount volume pH aqueous sample achieve highest efficiency. developed validated according Food Drug Administration guidelines demonstrated good linearity, accuracy, precision. range linearity from 1000 20,000 ng/mL 200 with correlation coefficient values 0.998 0.996, respectively. Selectivity studies revealed that no others peaks appeared retention times studied drugs. stability were also investigated through short term three cycles freeze–thaw, both drugs found stable. This analytical could be useful monitoring drug concentrations patients undergoing these COVID-19. In this work, first time, SULLME sensitive determination biological fluids. able determine therapeutic need sophisticated techniques like LC–MS. addition that, is considered simple green preparation comparison conventional methods.

Язык: Английский

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Recent analytical methodologies for the determination of anti-covid-19 drug therapies in various matrices: a critical review

RSC Advances, Год журнала: 2023, Номер 13(19), С. 13224 - 13239

Опубликована: Янв. 1, 2023

Since the discovery of first case infected with severe acute respiratory syndrome coronavirus-2 (SARS CoV-2) in Wuhan, China December 2019, it has turned into a global pandemic. According to World Health Organization (WHO) statistics, about 603.7 million confirmed coronavirus cases and 6.4 deaths have been reported. Remdesivir (RMD) was U.S. Food Drug Administration (FDA) approved antiviral drug for treatment pediatrics adults different disease severities, ranging from mild severe, both hospitalized non-hospitalized patients. Various regimens are used Covid-19 treatment, all which rely on use agents including ritonavir (RTN)/nirmatrelvir (NTV) combination, molnupiravir (MLP) favipiravir (FVP). Optimizing analytical methods selective sensitive quantification above-mentioned drugs pharmaceutical dosage forms biological matrices is must current Several techniques were reported estimation antivirals therapy. Chromatographic include Thin Layer Chromatography (TLC) densitometry, High Performance (HPTLC), Reversed Phase-High Liquid (RP-HPLC), Tandem Mass Spectrometry (HPLC-MS/MS) or Ultraviolet detectors (HPLC-UV), Ultra High-Performance (UHPLC-MS/MS) (UPLC-UV) Micellar (MLC). In addition other spectroscopic Paper Spray (PS-MS), UV-Visible Spectrophotometry, Spectrofluorimetry. Herein, we will focus clarification trendy, simple, rapid, accurate, precise, sensitive, selective, eco-friendly analysis anti-Covid-19 as well matrices.

Язык: Английский

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Population pharmacokinetics and pharmacodynamics of nirmatrelvir in Chinese patients with COVID‐19

Fundamental and Clinical Pharmacology, Год журнала: 2024, Номер 38(4), С. 767 - 779

Опубликована: Фев. 11, 2024

The pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of nirmatrelvir (NMV) are unknown in Chinese patients with COVID-19.

Язык: Английский

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Population Pharmacokinetics of Nirmatrelvir in Chinese Patients with COVID-19: Therapeutic Drug Monitoring and Dosing Regimen Selection in Clinical Practice

International Journal of Antimicrobial Agents, Год журнала: 2024, Номер 64(2), С. 107199 - 107199

Опубликована: Май 24, 2024

Язык: Английский

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Simultaneous measurement of COVID-19 treatment drugs (nirmatrelvir and ritonavir) in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study

Heliyon, Год журнала: 2024, Номер 10(11), С. e32187 - e32187

Опубликована: Май 30, 2024

PAXLOVID™ (Co-packaging of Nirmatrelvir with Ritonavir) has been approved for the treatment Coronavirus Disease 2019 (COVID-19). The goal experiment was to create an accurate and straightforward analytical method using ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) simultaneously quantify nirmatrelvir ritonavir in rat plasma, investigate pharmacokinetic profiles these drugs rats. After protein precipitation acetonitrile, nirmatrelvir, ritonavir, internal standard (IS) lopinavir were separated (UPLC). This separation achieved a mobile phase composed acetonitrile aqueous solution 0.1% formic acid, reversed-phase column binary gradient elution. Using multiple reaction monitoring (MRM) technology, analytes detected positive electrospray ionization mode. Favorable linearity observed calibration range 2.0–10000 ng/mL 1.0–5000 respectively, within plasma samples. lower limits quantification (LLOQ) attained 2.0 1.0 respectively. Both demonstrated inter-day intra-day precision below 15%, accuracies ranging from −7.6% 13.2%. Analytes extracted recoveries higher than 90.7% without significant matrix effects. Likewise, stability found meet requirements under different conditions. UPLC-MS/MS method, characterized by enabling precise effectively utilized vivo studies

Язык: Английский

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Development and validation of a new RP-UPLC method for the simultaneous estimation of nirmatrelvir and ritonavir in bulk and copacked tablet dosage forms

Research Journal of Pharmacy and Technology, Год журнала: 2023, Номер unknown, С. 4370 - 4376

Опубликована: Сен. 30, 2023

The objective of this work is to develop a simple, accurate, precise and validated RP-UPLC method for effective simultaneous determination nirmatrelvir ritonavir in bulk copacked tablet formulation. Separation drugs was optimized after several trials by changing mobile phase composition, stationary phase, flow rate column temperature. Finally the separation achieved on phenyl (100 x 2.1 mm, 1.7 µ) using isocratic elution with acetonitrile triethyl amine (30:70 v/v). A 0.5 mL/min. detector wavelength 267 nm utilizing PDA were given instrumental settings. Validation proposed carried out according International Council Harmonization (ICH) guidelines. system suitability parameters within limits, retention time (Rt) at 1.262 min. 1.873 respectively over total runtime five minutes. showed linearity between concentration range 37.5-225 µg/mL (R² = 0.99956) 25-150 0.9998). percentage recovery results standard addition found be 99.3 % - 100.3 %. specific, accurate robust. During stability tests, it can used routine analysis selected drugs.

Язык: Английский

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Analyzing Paxlovid: Examining Its Properties, Characteristics, and Analytical and Bio‐Analytical Methods–A Comprehensive Review

Separation Science Plus, Год журнала: 2024, Номер unknown

Опубликована: Окт. 7, 2024

ABSTRACT Paxlovid, a novel antiviral medication developed by Pfizer, has attracted considerable attention as coronavirus disease 2019 therapeutic since it may be effective in treating the severe acute respiratory syndrome type 2‐caused disease. Paxlovid is known combination therapy includes two agents, Nirmatrelvir and Ritonavir, which both are involved viral replication process inhibition. A further discussion of molecular structure, pharmacokinetics, pharmacodynamics components will help comprehend Paxlovid's mechanism impact effectiveness. High‐performance spectroscopic methods, including high‐performance liquid chromatography (HPLC), infrared, ultraviolet‐visible spectroscopy have been among methods employed for compound identification, quantification, structural elucidation. Bioanalytical also made significant contribution to evaluation pharmacokinetic parameters, bioavailability, metabolism biological matrices. LC‐tandem mass spectrometry (LC‐MS/MS) widely quantification its metabolites plasma, serum, other samples. This study brings forth an overview characteristics properties along with analytical bioanalytical assessment quantification.

Язык: Английский

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