Quantification of roxatidine in human plasma by liquid chromatography electrospray ionization tandem mass spectrometry: application to a bioequivalence study. 2008

Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
Department of Pharmaceutical Biochemistry, College of Pharmacy, Kyung Hee University, Hoegi-Dong, Dongdaemun-Ku, Seoul, South Korea.

A sensitive and specific method using a one-step liquid-liquid extraction (LLE) with ethyl acetate followed by high-performance liquid chromatography (HPLC) coupled with positive ion electrospray ionization tandem mass spectrometry (ESI-MS/MS) detection was developed and validated for the determination of roxatidine in human plasma using famotidine as an internal standard (IS). Data acquisition was carried out in multiple reaction monitoring (MRM) mode, by monitoring the transitions m/z 307.3-->107.1 for roxatidine and m/z 338.4-->189.1 for famotidine. Chromatographic separation was performed on a reverse phase Hydrosphere C(18) column at 0.2 mL min(-1) using a mixture of methanol-ammonium formate buffer as mobile phase (20:80, v/v; adjusted to pH 3.9 with formic acid). The achieved lower limit of quantification (LLOQ) was 1.0 ng mL(-1) and the standard calibration curve for roxatidine was linear (r(2)=0.998) over the studied range (1-1000 ng mL(-1)) with acceptable accuracy and precision. Roxatidine was found to be stable in human plasma samples under short-, long-term storage and processing conditions. The developed method was validated and successfully applied to the bioequivalence study of roxatidine administrated as a single oral dose (75 mg as roxatidine acetate hydrochloride) to healthy female Korean volunteers.

UI MeSH Term Description Entries
D010880 Piperidines A family of hexahydropyridines.
D004355 Drug Stability The chemical and physical integrity of a pharmaceutical product. Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012680 Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) Specificity,Sensitivity,Specificity and Sensitivity
D013810 Therapeutic Equivalency The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies
D015203 Reproducibility of Results The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results. Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D053719 Tandem Mass Spectrometry A mass spectrometry technique using two (MS/MS) or more mass analyzers. With two in tandem, the precursor ions are mass-selected by a first mass analyzer, and focused into a collision region where they are then fragmented into product ions which are then characterized by a second mass analyzer. A variety of techniques are used to separate the compounds, ionize them, and introduce them to the first mass analyzer. For example, for in GC-MS/MS, GAS CHROMATOGRAPHY-MASS SPECTROMETRY is involved in separating relatively small compounds by GAS CHROMATOGRAPHY prior to injecting them into an ionization chamber for the mass selection. Mass Spectrometry-Mass Spectrometry,Mass Spectrometry Mass Spectrometry,Mass Spectrometry, Tandem
D021241 Spectrometry, Mass, Electrospray Ionization A mass spectrometry technique used for analysis of nonvolatile compounds such as proteins and macromolecules. The technique involves preparing electrically charged droplets from analyte molecules dissolved in solvent. The electrically charged droplets enter a vacuum chamber where the solvent is evaporated. Evaporation of solvent reduces the droplet size, thereby increasing the coulombic repulsion within the droplet. As the charged droplets get smaller, the excess charge within them causes them to disintegrate and release analyte molecules. The volatilized analyte molecules are then analyzed by mass spectrometry. ESI Mass Spectrometry,Electrospray Ionization Mass Spectrometry,Mass Spectrometry, ESI,Spectrometry, ESI Mass

Related Publications

Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
January 2011, Arzneimittel-Forschung,
Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
January 2007, Die Pharmazie,
Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
March 2002, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences,
Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
February 2001, Journal of mass spectrometry : JMS,
Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
December 2004, Journal of mass spectrometry : JMS,
Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
April 2002, Journal of mass spectrometry : JMS,
Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
December 2001, Therapeutic drug monitoring,
Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
August 2006, Biomedical chromatography : BMC,
Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
May 2012, Arzneimittel-Forschung,
Ju-Hee Ryu, and Sang-Jun Choi, and Heon-Woo Lee, and Seung-Ki Choi, and Kyung-Tae Lee
August 2005, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences,
Copied contents to your clipboard!