A novel LC-TQ-MS/MS method for quantifying mefenamic acid-NDSRI (N-nitroso drug substance-related impurity) in mefenamic acid tablet and pediatric suspension dosage forms: a comparative study with a cost-effective white, green, and blue UPLC method.

ABSTRACT: The current research presents novel LC-TQ-MS/MS and cost-effective UPLC methods intended for the accurate quantification of mefenamic acid-N-nitroso drug substance-related impurity-NDSRI (N-MFA) in mefenamic acid (MFA) tablet and pediatric suspension dosage forms. The acceptable intake of N-MFA is derived from the TD50 (Median Toxic Dose-50%) value of N-nitroso diphenylamine. The analytical separation was achieved for the UPLC method using an XBridge BEH Shield RP18 Column (150 × 3.0 mm, 3.5 μm), employing 0.1% formic acid and acetonitrile as mobile phases in a gradient mode. A flow rate of 0.7 mL min^-1 was set for the pump, and the detection wavelength was 230 nm. LC-TQ-MS-MS analysis was accomplished utilizing a Xevo TQ-XS mass spectrometer with electrospray ionization in the

SUBMITTER: Nakka S 

PROVIDER: S-EPMC11748889 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature