Study of impurity carryover and impurity profile in Febuxostat drug substance by LC-MS/MS technique.
Summary of "Study of impurity carryover and impurity profile in Febuxostat drug substance by LC-MS/MS technique."
Febuxostat is used in the treatment of hyperuricemia and gout. Several impurities were detected in Febuxostat drug substance. Impurities were identified with the help of LC-MS/MS and were characterized after synthesis by IR and NMR. Reverse phase gradient system was used with Kromasil C18, 150mm×4.6mm, 5μm particle size column for the separation of impurities. Q-TOF mass spectrometer with electrospray ionization (ESI) source was used and operated in ESI positive mode, which gives exact mass up to four decimal places and fragmentation with mass accuracy, it is useful for the identification of impurities. Four impurities were identified as amide, sec-butyl, des-cyano and des-acid in Febuxostat drug analog. These impurities were further confirmed by NMR and FT-IR spectral data.
Affiliation
Unimark Remedies Ltd., 337-Kerala Nalasarovar Road, Ahmedabad 382220, Gujarat, India. mustakkadivar@yahoo.com
Journal Details
This article was published in the following journal.
Name: Journal of pharmaceutical and biomedical analysis
ISSN: 1873-264X
Pages: 749-57
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21840659
- DOI: http://dx.doi.org/10.1016/j.jpba.2011.07.039
Medical and Biotech [MESH] Definitions
Metabolic Detoxication, Drug
Reduction of pharmacologic activity or toxicity of a drug or other foreign substance by a living system, usually by enzymatic action. It includes those metabolic transformations that make the substance more soluble for faster renal excretion.
Drug Incompatibility
The quality of not being miscible with another given substance without a chemical change. One drug is not of suitable composition to be combined or mixed with another agent or substance. The incompatibility usually results in an undesirable reaction, including chemical alteration or destruction. (Dorland, 27th ed; Stedman, 25th ed)
Receptors, Drug
Proteins that bind specific drugs with high affinity and trigger intracellular changes influencing the behavior of cells. Drug receptors are generally thought to be receptors for some endogenous substance not otherwise specified.
Substance Withdrawal Syndrome
Physiological and psychological symptoms associated with withdrawal from the use of a drug after prolonged administration or habituation. The concept includes withdrawal from smoking or drinking, as well as withdrawal from an administered drug.
Tissue Distribution
Accumulation of a drug or chemical substance in various organs (including those not relevant to its pharmacologic or therapeutic action). This distribution depends on the blood flow or perfusion rate of the organ, the ability of the drug to penetrate organ membranes, tissue specificity, protein binding. The distribution is usually expressed as tissue to plasma ratios.
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