Document Detail

Simultaneous estimation of amlodipine and atenolol in human plasma: a sensitive LC-MS/MS method validation and its application to a clinical PK study.
MedLine Citation:
PMID:  23534427     Owner:  NLM     Status:  In-Data-Review    
Background: A highly sensitive, specific and rapid LC-ESI-MS/MS method has been developed and validated for simultaneous quantification of amlodipine (AMD) and atenolol (ATL) in human plasma (200 µl) using AMD-d4 and ATL-d7, respectively, as an internal standard (IS) as per the regulatory guidelines. Results: The SPE method was used to extract the analytes and IS from human plasma. The chromatographic resolution of AMD, ATL and corresponding IS was achieved using an isocratic flow on a C18 column. The total chromatographic run time was 3 min. A linear response function was established for the range of concentrations 50-8000 pg/ml and 10-800 ng/ml for AMD and ATL, respectively, in human plasma. Conclusion: The intra- and inter-day accuracy and precision values for AMD and ATL met the acceptance as per regulatory guidelines. The validated assay was applied to a fixed-dose combination of AMD and ATL (Adopin-AT(®)) PK study in humans.
Raja Reddy Kallem; Ramesh Mullangi; Kishore Kumar Hotha; Lk Ravindranath; Yn Spoorthy; Jvln Seshagirirao
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Bioanalysis     Volume:  5     ISSN:  1757-6199     ISO Abbreviation:  Bioanalysis     Publication Date:  2013 Apr 
Date Detail:
Created Date:  2013-03-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101512484     Medline TA:  Bioanalysis     Country:  England    
Other Details:
Languages:  eng     Pagination:  827-37     Citation Subset:  IM    
College of Pharmaceutical Sciences, Andhra University, Visakhapatnam 530 003, AP, India.
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