title: A high throughput and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the estimation of bisoprolol in human plasma using multiplexing technique.
abstract: A high throughput and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the estimation of bisoprolol in human plasma using multiplexing technique (two HPLC units connected to one MS). Bisoprolol was extracted from human plasma using solid-phase extraction technique using metoprolol as internal standard. A Betabasic 8 column provided chromatographic separation of analytes followed by detection with mass spectrometry. The mass transition ion-pair was followed as m/z 326.2-->116.1 for bisoprolol and m/z 268.2-->191.0 for metoprolol. The method involves a simple multiplexing, rapid solid-phase extraction, simple isocratic chromatography conditions and mass spectrometric detection which enable detection at sub-nanogram levels. The proposed method has been validated for a linear range of 0.5-70.0 ng/mL with correlation coefficient > or =0.9991. The precision and accuracy were within 10% for intra-HPLC runs and inter-HPLC runs. The overall recoveries for bisoprolol and metoprolol were 93.89% and 77.65%, respectively. Total MS run time was 0.90 min only. The developed method was applied for the determination of pharmacokinetic parameters of bisoprolol following a single oral administration of a 10mg bisoprolol tablet in 18 healthy male volunteers.
authors.affiliation: Bioanalytical Laboratory, Torrent Research Centre, Village Bhat, Gandhinagar 382428, Gujarat, India. jigneshbhatt@torrentpharma.com
authors.forename: Jignesh
authors.initials: J
authors.lastname: Bhatt
authors.forename: Gunta
authors.initials: G
authors.lastname: Subbaiah
authors.forename: Sandeep
authors.initials: S
authors.lastname: Kambli
authors.forename: Bhavin
authors.initials: B
authors.lastname: Shah
authors.forename: Mehul
authors.initials: M
authors.lastname: Patel
authors.forename: Ashish
authors.initials: A
authors.lastname: Saxena
authors.forename: Ashok
authors.initials: A
authors.lastname: Baliga
authors.forename: Samita
authors.initials: S
authors.lastname: Nigam
authors.forename: Hetal
authors.initials: H
authors.lastname: Parekh
authors.forename: Gunvat
authors.initials: G
authors.lastname: Yadav
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000097:blood*; D017298:Bisoprolol / Q000097:blood*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006801:Humans; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D000319:Adrenergic beta-Antagonists; D017298:Bisoprolol