Synthesis and Trace-Level Quantification of Mutagenic and Cohort-of-Concern Ciprofloxacin Nitroso Drug Substance-Related Impurities (NDSRIs) and Other Nitroso Impurities Using UPLC-ESI-MS/MS-Method Optimization Using I-Optimal Mixture Design.

Globally, the pharmaceutical industry has been facing challenges from nitroso drug substance-related impurities (NDSRIs). In the current study, we synthesized and developed a rapid new UPLC-MS/MS method for the trace-level quantification of ciprofloxacin NDSRIs and a couple of N-nitroso impurities simultaneously. (Q)-SAR methodology was employed to assess and categorize the genotoxicity of all ciprofloxacin -nitroso impurities.

A sensitive ultra-performance liquid chromatography-tandem mass spectrometry method for the simultaneous quantification of assay and trace-level genotoxic tosylate analogs (methyl and ethyl) in empagliflozin and its tablet dosage forms.

This study performed the simultaneous quantification of assay and two alkyl sulfonate (tosylate) analogs of empagliflozin (EGZ), specifically methyl 4-methyl benzene sulfonate (MMBS) and ethyl 4-methyl benzene sulfonate (EMBS) in EGZ, and its finished dosage form using an accurate and sensitive ultra-performance liquid chromatography-mass spectrometry method. The separation was achieved on a Waters Acquity BEH Shield RP18 (100 × 2.1 mm, 1.

Investigating Betrixaban Maleate drug degradation profiles, isolation and characterization of unknown degradation products by mass-triggered preparative HPLC, HRMS, and NMR.

Betrixaban Maleate, a novel oral, once-daily factor Xa inhibitor drug substance, was subjected to stress testing under a wide range of degradation conditions, including acidic hydrolysis, alkaline hydrolysis, oxidative, thermal, and photolytic, to determine its inherent stability. The drug was biodegradable in acidic and alkaline environments, and three new degradation products were identified. Two degraded products are formed in an acidic environment, while the third is in alkaline conditions.

A sensitive UPLC-MS/MS method for the simultaneous assay and trace level genotoxic impurities quantification of SARS-CoV-2 inhibitor-Molnupiravir in its pure and formulation dosage forms using fractional factorial design.

Two potential genotoxic impurities were identified (PGTIs)-viz. 4-amino-1-((2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1H)-one (PGTI-1), and 1-(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2,4(1H,3H)-one (PGTI-II) in the Molnupiravir (MOPR) synthetic routes. COVID-19 disease was treated with MOPR when mild to moderate symptoms occurred.

Simultaneous quantification of lidocaine and prilocaine in human plasma by LC-MS/MS and its application in a human pharmacokinetic study.

Objective: The aim of the work was to develop and validate a simple, sensitive and selective Liquid chromatography with Mass spectroscopic method for simultaneous quantification of lidocaine and prilocaine in human plasma.

Design And Methods: Analytes and the internal standards from human plasma were extracted by using solid- phase extraction technique using Waters Oasis® HLB 1 ​cc (30 ​mg) cartridges. The reconstituted samples were chromatographed on Phenomenex Kinetex EVO 4.

Determination of ospemifene in human plasma by LC-MS/MS and its application to a human pharmacokinetic study.

A highly sensitive, specific and rapid liquid chromatography-tandem mass spectrometry (LC-MS/MS) analytical method has been developed and validated for the determination of ospemifene in human plasma using ospemifene-d as an internal standard. Solid-phase extraction technique with Phenomenex Strata X-33 μm polymeric sorbent cartridges (30 mg/1 mL) was used to extract the analytes from the plasma. The chromatographic separation was achieved on Agilent Eclipse XDB-Phenyl, 4.

Bioanalytical technique for determination of tasimelteon in human plasma by LC-MS/MS and its application to pharmacokinetic study in humans.

A highly sensitive, specific and rapid liquid chromatography-tandem mass spectrometry technique for the quantification of tasimelteon in human plasma has been developed and validated using tasimelteon-d as internal standard. Liquid-liquid extraction technique with ethyl acetate was used for extraction of tasimelteon from the plasma. The chromatographic separation was achieved on an Agilent Zorbax, Eclipse, C (4.