Optimization of LC-MS/MS Analytical Method for Trace Level Quantification of Potential Genotoxic Impurities in Siponimod Pure Drug and Formulations DOI Open Access
Penchala Reddy Vaka, Battula Sreenivasa Rao,

N. Bharathi

et al.

International Journal of Advancement in Life Sciences Research, Journal Year: 2024, Volume and Issue: 07(02), P. 81 - 91

Published: Jan. 1, 2024

The generation of single or multiple genotoxic impurities during synthesis siponimod should be avoided for production safe formulation. Technically, complete elimination was not possible and hence there is a need to propose an accurate method trace level detection impurities.Method optimization studies were conducted by analysis standard solution in various parameters. results noticed every varied condition tabulated finalizing the appropriate conditions analyzing siponimod. optimized consists waters C18 (150 × 4.6 mm; 5 μm) column, ammonium acetate (0.02M) at pH 4.2 (fixed with 1 % formic acid) methanol 45:55 (v/v) 0.5 mL/min flow rate. mass analyser operated reaction positive ion mode characteristic transition m/z 517 (parent ion)and 213 (product ion) siponimod, 434(parent 173 ion)for alcohol 432(parent and172 aldehyde impurity. No impurity unwanted compounds detected both LC chromatograms spectra, confirming specificity.Validation parameters including linearity, precision, recovery, ruggedness, robustness yielded acceptable results. suitable assessing potential manufacturing pharmaceutical products.

Language: Английский

Development with greenness evaluation and validation of stability indicating ion-pair reverse phase HPLC method for determination of related substances and assay of Nirmatrelvir drug substance DOI

Sonali Mehendale-Munj,

Manoj A. Mangukiya,

Aman A. Desai

et al.

Analytical Chemistry Letters, Journal Year: 2025, Volume and Issue: 15(1), P. 65 - 82

Published: Jan. 2, 2025

Language: Английский

Citations

0
First analytical confirmation of drug-induced crystal nephropathy in felines caused by GS-441524, the active metabolite of Remdesivir DOI Creative Commons
Amelia Furbish, Marissa Allinder, Glenn Austin

et al.

Journal of Pharmaceutical and Biomedical Analysis, Journal Year: 2024, Volume and Issue: 247, P. 116248 - 116248

Published: May 22, 2024

GS-441524 is an adenosine nucleoside antiviral demonstrating significant efficacy in the treatment of feline infectious peritonitis (FIP), otherwise fatal illness, resulting from infection with coronavirus. However, following emergence COVID-19, veterinary development was halted, and Gilead pursued clinical a pro-drug, approval Remdesivir under FDA emergency use authorization. Despite lack regulatory approval, available without prescription through various unlicensed online distributors commonly purchased by pet owners for FIP. Herein, we report data obtained analytical characterization two renal calculi, propensity to cause toxicity drug-induced crystal nephropathy vivo. As definitive diagnosis requires confirmation lithogenic material accurately attribute mechanism toxicity, stone composition crystalline matrix were characterized using ultra-performance liquid chromatography photodiode array detection (UPLC-PDA), mass spectrometry (LCMS), nuclear magnetic resonance (NMR) spectroscopy, X-ray powder diffraction (XRD), Fourier-transform infrared spectroscopy (FTIR). This work serves provide first GS-441524-induced effort support toxicologic identification adverse effects caused administration or any pro-drug thereof.

Language: Английский

Citations

2
Favipiravir, remdesivir, and lopinavir: metabolites, degradation products and their analytical methods DOI
Mir Saleh Hoseininezhad-Namin, Elaheh Rahimpour, Abolghasem Jouyban

et al.

Drug Metabolism Reviews, Journal Year: 2024, Volume and Issue: 56(2), P. 127 - 144

Published: March 6, 2024

Severe acute respiratory syndrome 2 (SARS-CoV-2) caused the emergence of COVID-19 pandemic all over world. Several studies have suggested that antiviral drugs such as favipiravir (FAV), remdesivir (RDV), and lopinavir (LPV) may potentially prevent spread virus in host cells person-to-person transmission. Simultaneously with widespread use these drugs, their stability action mechanism also attracted attention many researchers. This review focuses on mechanism, metabolites degradation products (FAV, RDV LPV) demonstrates various methods for quantification discrimination different biological samples. Herein, instrumental analysis main form or metabolite are classified into two types: optical chromatography which last one combination detectors provides a powerful method routine analyses. Some representative reported this details them carefully explained. It is hoped will be good guideline study provide better understanding from aspects investigated study.

Language: Английский

Citations

1
Rapid and ecofriendly ultra performance liquid chromatographic analytical methodology for the simultaneous determination of four drugs included in COVID-19 treatment protocol DOI

Ekram A. Ghozzy,

Nahed El‐Enany,

Manar M. Tolba

et al.

Microchemical Journal, Journal Year: 2024, Volume and Issue: 205, P. 111178 - 111178

Published: July 11, 2024

Language: Английский

Citations

1
Assessment of Analytical Techniques for Precise Quantification of Four Antiviral Drugs in Pharmaceutical Research and Development: A Comprehensive Review DOI
Akhil Gupta, Shilpi Pathak

Current Pharmaceutical Analysis, Journal Year: 2024, Volume and Issue: 20(6), P. 409 - 424

Published: July 1, 2024

: Precise measurement of drug concentration in pharmaceutical research is critical, especially for anti-viral drugs like boceprevir, elvitegravir, indinavir, and saquinavir that combat viral infections. It well-known analytical techniques play an imperative role identifying characterizing active ingredients biological samples formulations. Moreover, precise assessment directly influences safety, stability, efficacy while providing in-depth insight into pharmacokinetics. Other than this, also aid impurities, deteriorated products, potential pollutants. Thus, reliable methods have become crucial addressing challenges imposed by complex The most commonly used technique UV spectrophotometry, which does not the high sensitivity to detect In contrast, Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) merges two techniques, chromatography mass spectrometry, accurately quantify samples. Furthermore, Ultra-Performance Chromatography (UPLC) provides enhanced resolution, faster analysis short duration, low solvent consumption contrast HPLC. This comprehensive review aims critically assess each approach's accuracy, applicability, selectivity, limitation provide valuable insights researchers analysts. Understanding weaknesses strengths these will enable select suitable method based on their needs requirements quality assessment, quantification, optimal therapeutic efficiency. Eventually, this intends advance development, specifically drugs, ensuring effective secure administration therapies.

Language: Английский

Citations

0
Optimization of LC-MS/MS Analytical Method for Trace Level Quantification of Potential Genotoxic Impurities in Siponimod Pure Drug and Formulations DOI Open Access
Penchala Reddy Vaka, Battula Sreenivasa Rao,

N. Bharathi

et al.

International Journal of Advancement in Life Sciences Research, Journal Year: 2024, Volume and Issue: 07(02), P. 81 - 91

Published: Jan. 1, 2024

The generation of single or multiple genotoxic impurities during synthesis siponimod should be avoided for production safe formulation. Technically, complete elimination was not possible and hence there is a need to propose an accurate method trace level detection impurities.Method optimization studies were conducted by analysis standard solution in various parameters. results noticed every varied condition tabulated finalizing the appropriate conditions analyzing siponimod. optimized consists waters C18 (150 × 4.6 mm; 5 μm) column, ammonium acetate (0.02M) at pH 4.2 (fixed with 1 % formic acid) methanol 45:55 (v/v) 0.5 mL/min flow rate. mass analyser operated reaction positive ion mode characteristic transition m/z 517 (parent ion)and 213 (product ion) siponimod, 434(parent 173 ion)for alcohol 432(parent and172 aldehyde impurity. No impurity unwanted compounds detected both LC chromatograms spectra, confirming specificity.Validation parameters including linearity, precision, recovery, ruggedness, robustness yielded acceptable results. suitable assessing potential manufacturing pharmaceutical products.

Language: Английский

Citations

0