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Liquid Chromatography Tandem Mass Spectrometric Method for Quantification of Margetuximab in Rat Plasma and Application to a Pharmacokinetic Study.
Gaddey, Pridhvi Krishna; Sundararajan, Raja.
Afiliación
  • Gaddey PK; Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, 530 045, Andhra Pradesh, India.
  • Sundararajan R; Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, 530 045, Andhra Pradesh, India. sraja61@gmail.com.
AAPS PharmSciTech ; 25(2): 33, 2024 Feb 08.
Article en En | MEDLINE | ID: mdl-38332459
ABSTRACT
Margetuximab was approved for the treatment of advanced HER2+ breast cancer. A feasible analytical technique that can measure this drug was obligatory. In light of this, a novel and thoroughly validated liquid chromatographic (LC)-tandem mass spectrometric (MS/MS) approach was developed for the quantification of margetuximab in rat plasma. The liquid-liquid extraction method was used to extract the analyte from rat plasma. The analyte was separated using acetonitrile and formic acid buffer (3070) as a mobile phase on Waters, alliance e-2695 model HPLC having Symmetry C18 column, 150 mm × 4.6 mm, 3.5-µm column. The overall runtime was 6 min at a flow rate of 1.0 ml/min. The method showed significant sensitivity and acceptable linearity over the concentration range of 6-120 ng/ml. Accuracy was within 98.51-99.92%. The intraday precision ranged between 0.41 and 8.98% CV. Also, the findings of pharmacokinetic parameters such as Cmax, tmax, AUC0-∞, AUC0-t, and half-life results of margetuximab showed that the technique was helpful for accurately measuring drug concentrations in rat plasma. The method that was developed was useful and effective for quantifying margetuximab.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Espectrometría de Masas en Tándem / Anticuerpos Monoclonales Tipo de estudio: Prognostic_studies Límite: Animals Idioma: En Revista: AAPS PharmSciTech Asunto de la revista: FARMACOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: India Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Espectrometría de Masas en Tándem / Anticuerpos Monoclonales Tipo de estudio: Prognostic_studies Límite: Animals Idioma: En Revista: AAPS PharmSciTech Asunto de la revista: FARMACOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: India Pais de publicación: Estados Unidos