Stability indicating RP-UPLC technique was developed for the simultaneous quantification of glycopyrrolate, methylparaben, and propylparaben in glycopyrrolate oral solution. The method was established by using gradien...Stability indicating RP-UPLC technique was developed for the simultaneous quantification of glycopyrrolate, methylparaben, and propylparaben in glycopyrrolate oral solution. The method was established by using gradient UPLC and a Waters Acquity UPLC BEH C18, 100 mm 2.1 mm, i.d 1.7 μm particle size column with a gradient program of mobile phase A and mobile phase B with a flow rate of 0.25 mL/minute, UV wavelength detection at 222 nm, column temperature of 40°C, injection volume of 2 μL, mobile phase A contains 0.05% trifluoro acetic acid in water and Acetonitrile (90:10) v/v and mobile phase-B contains 0.05% trifluoro acetic acid in water and Acetonitrile (10:90) v/v. The current research describes a single UPLC method for developing an assay method for Glycopyrrolate Oral solution that includes Glycopyrrolate (Active), Methylparaben (Preservative), and Propylparaben (Preservative). The assay method was validated in accordance with ICH guidelines. The retention times of glycopyrrolate, methyl paraben and propylparaben were 6.051 min, 3.458 min and 8.095 min, respectively. Linearity range of glycopyrrolate, methyl paraben and propylparaben were in the range of 4 - 32 μg per mL, 35 - 290 μg per mL and 4 - 32 μg per mL, respectively. Recovery of glycopyrrolate, methylparaben and propylparaben ranged from 100.1% to 98.9%, 100.2% - 100.8%, and 100.2% - 100.8%. Validation of analytical method demonstrated that the method is suitable, specific, linear, accurate, precise, rugged and stability indicating for estimating three components in the pharmaceutical dosage form.展开更多
Parabens(PBs),especially propylparaben,commonly used in consumer products,pose environmental and health concerns.This study explored propylparaben’s cytotoxicity on HTR-8/SVneo human trophoblast cells,revealing signi...Parabens(PBs),especially propylparaben,commonly used in consumer products,pose environmental and health concerns.This study explored propylparaben’s cytotoxicity on HTR-8/SVneo human trophoblast cells,revealing significant dosedependent cytotoxic effects,particularly post 48-h exposure.Elevated propylparaben levels triggered apoptosis,evidenced by increased Bax and activated Caspase-3,and induced the G0/G1 cell cycle arrest.Concurrently,an increase in reactive oxygen species and reduced mitochondrial membrane potential indicated oxidative stress and mitochondrial dysfunction.Although Nacetylcysteine(NAC)treatment reduced oxidative stress,cell invasiveness persisted,suggesting propylparaben might affect cell migration through nonoxidative mechanisms.Integrated transcriptome analysis through RNA sequencing revealed 3488 differentially expressed genes affected by propylparaben,highlighting changes in pathways like apoptosis and cell cycle regulation and identifying seven hub genes as potential biomarkers for pregnancy-related complications.This study comprehensively demonstrates the cytotoxic effects of propylparaben on human trophoblast cells,notably through apoptosis induction and cell cycle disruption,thereby providing crucial insights into its potential risks for reproductive health.展开更多
文摘Stability indicating RP-UPLC technique was developed for the simultaneous quantification of glycopyrrolate, methylparaben, and propylparaben in glycopyrrolate oral solution. The method was established by using gradient UPLC and a Waters Acquity UPLC BEH C18, 100 mm 2.1 mm, i.d 1.7 μm particle size column with a gradient program of mobile phase A and mobile phase B with a flow rate of 0.25 mL/minute, UV wavelength detection at 222 nm, column temperature of 40°C, injection volume of 2 μL, mobile phase A contains 0.05% trifluoro acetic acid in water and Acetonitrile (90:10) v/v and mobile phase-B contains 0.05% trifluoro acetic acid in water and Acetonitrile (10:90) v/v. The current research describes a single UPLC method for developing an assay method for Glycopyrrolate Oral solution that includes Glycopyrrolate (Active), Methylparaben (Preservative), and Propylparaben (Preservative). The assay method was validated in accordance with ICH guidelines. The retention times of glycopyrrolate, methyl paraben and propylparaben were 6.051 min, 3.458 min and 8.095 min, respectively. Linearity range of glycopyrrolate, methyl paraben and propylparaben were in the range of 4 - 32 μg per mL, 35 - 290 μg per mL and 4 - 32 μg per mL, respectively. Recovery of glycopyrrolate, methylparaben and propylparaben ranged from 100.1% to 98.9%, 100.2% - 100.8%, and 100.2% - 100.8%. Validation of analytical method demonstrated that the method is suitable, specific, linear, accurate, precise, rugged and stability indicating for estimating three components in the pharmaceutical dosage form.
基金supported by Tianjin Key Laboratory of Risk Assessment and Control Technology for Environment and Food Safety,Tianjin Institute of Environmental and Operational Medicine.
文摘Parabens(PBs),especially propylparaben,commonly used in consumer products,pose environmental and health concerns.This study explored propylparaben’s cytotoxicity on HTR-8/SVneo human trophoblast cells,revealing significant dosedependent cytotoxic effects,particularly post 48-h exposure.Elevated propylparaben levels triggered apoptosis,evidenced by increased Bax and activated Caspase-3,and induced the G0/G1 cell cycle arrest.Concurrently,an increase in reactive oxygen species and reduced mitochondrial membrane potential indicated oxidative stress and mitochondrial dysfunction.Although Nacetylcysteine(NAC)treatment reduced oxidative stress,cell invasiveness persisted,suggesting propylparaben might affect cell migration through nonoxidative mechanisms.Integrated transcriptome analysis through RNA sequencing revealed 3488 differentially expressed genes affected by propylparaben,highlighting changes in pathways like apoptosis and cell cycle regulation and identifying seven hub genes as potential biomarkers for pregnancy-related complications.This study comprehensively demonstrates the cytotoxic effects of propylparaben on human trophoblast cells,notably through apoptosis induction and cell cycle disruption,thereby providing crucial insights into its potential risks for reproductive health.
