Research Publications
A curated collection of scientific articles and studies showcasing our contributions to pharmaceutical research, innovation, and evidence-based advancements.
Our specializations support pharmaceutical companies across the critical stages of research, testing, validation, and clinical evaluation, delivering reliable scientific solutions backed by advanced technology, regulatory compliance, and experienced professionals.
Date Published: May 2021
Rapid LC-MS/MS Method for Favipiravir Bioanalysis in Human Plasma
This study presents a novel, sensitive LC-MS/MS method for quantifying favipiravir, a potential antiviral for COVID-19, in human plasma. Using simple protein precipitation and precise chromatographic separation, the method was fully validated according to US-FDA guidelines. It was successfully applied to assess the pharmacokinetics and bioequivalence of a new favipiravir formulation in healthy Egyptian volunteers, supporting reliable clinical evaluation.
Date Published: August 2019
UPLC-MS/MS Method for Flibanserin Bioanalysis in Human Plasma
This study developed a rapid and highly sensitive UPLC-MS/MS method for measuring flibanserin in human plasma using flibanserin d4 as an internal standard. Plasma samples were processed via protein precipitation and separated on a Kinetex C18 column. The method, validated according to US-FDA guidelines, demonstrated excellent linearity, precision, and accuracy over 5–1000 ng/mL, with a run time under 2 minutes. It was successfully applied to a pharmacokinetic study in healthy female volunteers following a single 100 mg oral dose.
Date Published: September 2018
Pharmacokinetic Evaluation of Daclatasvir and Ledipasvir in Healthy Volunteers
A simple, highly sensitive spectrofluorimetric method was developed and fully validated for simultaneous determination of Daclatasvir and Ledipasvir in tablets and human plasma. The method measures native fluorescence of each compound in methanol or acetonitrile, with excellent linearity and correlation. Analytes were extracted using methanol and acetonitrile, achieving low limits of quantification. Validation followed FDA bioanalytical guidelines, and the method was successfully applied to estimate pharmacokinetic parameters after oral administration of the tablets in healthy volunteers.
Date Published: May 2021
Rapid LC-MS/MS Method for Favipiravir Bioanalysis in Human Plasma
This study presents a novel, sensitive LC-MS/MS method for quantifying favipiravir, a potential antiviral for COVID-19, in human plasma. Using simple protein precipitation and precise chromatographic separation, the method was fully validated according to US-FDA guidelines. It was successfully applied to assess the pharmacokinetics and bioequivalence of a new favipiravir formulation in healthy Egyptian volunteers, supporting reliable clinical evaluation.
Date Published: August 2019
UPLC-MS/MS Method for Flibanserin Bioanalysis in Human Plasma
This study developed a rapid and highly sensitive UPLC-MS/MS method for measuring flibanserin in human plasma using flibanserin d4 as an internal standard. Plasma samples were processed via protein precipitation and separated on a Kinetex C18 column. The method, validated according to US-FDA guidelines, demonstrated excellent linearity, precision, and accuracy over 5–1000 ng/mL, with a run time under 2 minutes. It was successfully applied to a pharmacokinetic study in healthy female volunteers following a single 100 mg oral dose.
Date Published: September 2018
Pharmacokinetic Evaluation of Daclatasvir and Ledipasvir in Healthy Volunteers
A simple, highly sensitive spectrofluorimetric method was developed and fully validated for simultaneous determination of Daclatasvir and Ledipasvir in tablets and human plasma. The method measures native fluorescence of each compound in methanol or acetonitrile, with excellent linearity and correlation. Analytes were extracted using methanol and acetonitrile, achieving low limits of quantification. Validation followed FDA bioanalytical guidelines, and the method was successfully applied to estimate pharmacokinetic parameters after oral administration of the tablets in healthy volunteers.
Date Published: June 2018
Simultaneous LC-MS/MS Determination of Sofosbuvir and Daclatasvir in Human Plasma
Here’s a homepage-ready version for this publication with a separate publication date: Title: Simultaneous LC-MS/MS Determination of Sofosbuvir and Daclatasvir in Human Plasma Summary: A simple, highly sensitive LC-MS/MS method was developed and fully validated for simultaneous measurement of the antiviral drugs Sofosbuvir and Daclatasvir in human plasma, using Tadalafil as internal standard. Samples were extracted using liquid-liquid extraction and separated on a Zorbax SB-C18 column with isocratic elution. Quantification was performed with an API4500 triple quadrupole mass spectrometer in positive electrospray ionization mode. Validation followed FDA bioanalytical guidelines, confirming linearity, precision, accuracy, and stability. This method has been successfully applied to pharmacokinetic and bioequivalence studies, as well as therapeutic drug monitoring for dual combination therapy in Hepatitis C genotype 3 patients.