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Sensitive LC-MS/MS Method for the Simultaneous Determination of Bendamustine and its Active Metabolite, γ-Hydroxybendamustine in Small Volume Mice and Dog Plasma and its Application to a Pharmacokinetic Study in Mice and Dogs.
Chandrashekar, Devaraj V; Suresh, Ponnayyan S; Kumar, Rajnish; Bhamidipati, Ravi Kanth; Mullangi, Ramesh; Richter, Wolfgang; Srinivas, Nuggehally R.
Afiliación
  • Chandrashekar DV; Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Yeshwanthpur, Bangalore, India.
  • Suresh PS; Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Yeshwanthpur, Bangalore, India.
  • Kumar R; Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Yeshwanthpur, Bangalore, India.
  • Bhamidipati RK; Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Yeshwanthpur, Bangalore, India.
  • Mullangi R; Drug Metabolism and Pharmacokinetics, Jubilant Biosys Ltd, Yeshwanthpur, Bangalore, India.
  • Richter W; TUBE Pharmaceuticals GmbH, Wien, Austria.
  • Srinivas NR; Suramus Bio, Drug Development, J. P. Nagar, Bangalore, India.
Drug Res (Stuttg) ; 67(9): 497-508, 2017 Sep.
Article en En | MEDLINE | ID: mdl-28561238
A highly sensitive, specific and rapid LC-ESI-MS/MS method has been developed and validated for the simultaneous quantification of bendamustine (BM) and γ-hydroxybendamustine (HBM) in small volume (20 µL) mice and dog plasma using phenacetin as an internal standard (IS) as per regulatory guidelines. Both the analytes and IS were extracted from mice and dog plasma using a liquid-liquid extraction method. Chromatography was achieved on Atlantis dC18 column using an isocratic mobile phase (0.2% formic acid:acetonitrile, 25:75) at a flow rate of 0.40 mL/min. The total chromatographic run time was 3.0 min and the elution of BM, HBM and IS occurred at ~1.2, 1.2 and 2.0 min, respectively. A linear response function was established 0.11-518 ng/mL for both the analytes in mice and dog plasma. The intra- and inter-day accuracy and precisions were in the range of 3.46-12.9 and 3.63-8.23%; 1.15-9.00 and 7.86-9.49% for BM and HBM, respectively in mice plasma and 2.15-6.49 and 1.73-13.1%; 4.35-13.9 and 4.33-10.5% for BM and HBM, respectively in dog plasma. This novel method has been applied to a pharmacokinetic study in mice and dogs.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cromatografía Liquida / Antineoplásicos Alquilantes / Espectrometría de Masas en Tándem / Clorhidrato de Bendamustina Tipo de estudio: Diagnostic_studies Límite: Animals Idioma: En Revista: Drug Res (Stuttg) Año: 2017 Tipo del documento: Article País de afiliación: India Pais de publicación: Alemania

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cromatografía Liquida / Antineoplásicos Alquilantes / Espectrometría de Masas en Tándem / Clorhidrato de Bendamustina Tipo de estudio: Diagnostic_studies Límite: Animals Idioma: En Revista: Drug Res (Stuttg) Año: 2017 Tipo del documento: Article País de afiliación: India Pais de publicación: Alemania