title: Rapid, simple and highly sensitive LC-ESI-MS/MS method for the quantification of tamsulosin in human plasma.
abstract: A simple, rapid, sensitive and specific liquid chromatography-tandem mass spectrometry method was developed and validated for quantification of tamsulosin (I), a highly selective alpha1-adrenoceptor antagonist used for the treatment of patients with symptomatic benign prostatic hyperplasia. The analyte and internal standard, mosapride (II) were extracted by liquid-liquid extraction with diethyl ether-dichloromethane (70:30, v/v) using a Glas-Col Multi-Pulse Vortexer. The chromatographic separation was performed on a reverse phase Waters symmetry C18 column with a mobile phase of 0.03% formic acid-acetonitrile (30:70, v/v). The protonated analyte was quantitated in positive ionization by multiple reaction monitoring with a mass spectrometer. The mass transitions m/z 409.1 solidus in circle 228.1 and m/z 422.3 solidus in circle 198.3 were used to measure I and II, respectively. The assay exhibited a linear dynamic range of 0.1-50.0 ng/mL for tamsulosin in human plasma. The lower limit of quantitation was 100 pg/mL with a relative standard deviation of less than 10%. Acceptable precision and accuracy were obtained for concentrations over the standard curve ranges. A run time of 2.0 min for each sample made it possible to analyze a throughput of more than 400 human plasma samples per day. The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies.
authors.affiliation: Biopharmaceutical Research, Suven Life Sciences Ltd, Serene Chambers, Road 7, Banjara Hills, Hyderabad 500034, India. nvsrk@suven.com
authors.forename: N V S
authors.initials: NV
authors.lastname: Ramakrishna
authors.forename: K N
authors.initials: KN
authors.lastname: Vishwottam
authors.forename: S
authors.initials: S
authors.lastname: Manoj
authors.forename: M
authors.initials: M
authors.lastname: Koteshwara
authors.forename: S
authors.initials: S
authors.lastname: Wishu
authors.forename: D P
authors.initials: DP
authors.lastname: Varma
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000097:blood* / Q000493:pharmacokinetics; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D006801:Humans; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D013449:Sulfonamides / Q000097:blood* / Q000493:pharmacokinetics; D000077409:Tamsulosin
chemical_list: D000317:Adrenergic alpha-Antagonists; D013449:Sulfonamides; D000077409:Tamsulosin