An overview of various validated HPLC and LC-MS/MS methods for quantitation of drugs in bile: challenges and considerations.
Summary of "An overview of various validated HPLC and LC-MS/MS methods for quantitation of drugs in bile: challenges and considerations."
Although plasma/serum is the preferred matrix for the characterization of pharmacokinetic parameters, recent years have witnessed the emergence of bile matrix as another tool for refining the pharmacokinetic disposition of drug(s) and the associated metabolite(s). The biliary excretion mechanism represents an important path for drug elimination through feces. Also, there are numerous examples in which bile samples have been shown to concentrate both drug and its metabolite(s) in a much higher proportion as compared with the circulating blood levels and may act as a reservoir for the re-entry of the drug and its metabolite(s) to the systemic circulation once the bile gets drained into the small intestine. Firstly, the review provides a comprehensive overview of various analytical methods that have been adopted for bile sample analysis with a description of extraction steps, chromatography and validation protocol. Secondly, it provides a discussion on bioanalytical related strategies including bile sample collection requirements. Thirdly, a brief discussion on fit-for-use method strategy is also presented to enable an optimum allotment of resources for bile related analysis; and finally, the use of bile matrix in several mechanistic studies to probe efflux mechanisms and/or drug-drug interaction potential has been presented with relevant case studies. Copyright © 2010 John Wiley & Sons, Ltd.
Affiliation
Vanthys Pharmaceutical Development (Pvt) Ltd, Phoenix Pinnacle, Ulsoor Road, Bangalore-560 001, India. nuggehally.srinivas@vanthys.net.
Journal Details
This article was published in the following journal.
Name: Biomedical chromatography : BMC
ISSN: 1099-0801
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21061454
- DOI: http://dx.doi.org/10.1002/bmc.1532
Medical and Biotech [MESH] Definitions
Bile Canaliculi
Minute intercellular channels that occur between liver cells and carry bile towards interlobar bile ducts. Also called bile capillaries.
Bile Ducts
The channels that collect and transport the bile secretion from the BILE CANALICULI, the smallest branch of the BILIARY TRACT in the LIVER, through the bile ductules, the bile ducts out the liver, and to the GALLBLADDER for storage.
Liver Cirrhosis, Biliary
FIBROSIS of the hepatic parenchyma due to obstruction of BILE flow (CHOLESTASIS) in the intrahepatic or extrahepatic bile ducts (BILE DUCTS, INTRAHEPATIC; BILE DUCTS, EXTRAHEPATIC). Primary biliary cirrhosis involves the destruction of small intra-hepatic bile ducts and bile secretion. Secondary biliary cirrhosis is produced by prolonged obstruction of large intrahepatic or extrahepatic bile ducts from a variety of causes.
Cholestasis, Intrahepatic
Impairment of bile flow due to injury to the HEPATOCYTES; BILE CANALICULI; or the intrahepatic bile ducts (BILE DUCTS, INTRAHEPATIC).
Bile Duct Diseases
Diseases in any part of the ductal system of the BILIARY TRACT from the smallest BILE CANALICULI to the largest COMMON BILE DUCT.
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