LC-MS/MS Bioanalytical Method for the Quantitative Analysis of Nifedipine, Bisoprolol, and Captopril in Human Plasma: Application to Pharmacokinetic Studies

In this study, the development and validation of an accurate and highly sensitive LC-MS/MS method were performed for the estimation of nifedipine, bisoprolol, and captopril in real human plasma. Liquid-liquid extraction using tert-butyl methyl ether was efficiently applied for extraction of the analytes from plasma samples. The chromatographic separation was carried out using an isocratic elution mode on the X-terra MS C18 column (4.6 × 50 mm, 3.5 μm). The mobile phase consisted of methanol: 0.1 % formic acid (95:5, v/v) for determination of nifedipine and bisoprolol and acetonitrile: 0.1 % formic acid (70:30, v/v) for determination of captopril with a flow rate of 0.5 mL/min. Acceptable results regarding the different validation characteristics of the analytes were obtained in accordance with US-FDA recommendations for bioanalytical methods. The developed approach was linear over concentration ranges of 0.5-130.0, 50.0-4500.0, and 0.3-30.0 ng/mL for nifedipine, captopril, and bisoprolol, respectively. The method revealed a sufficient lower limit of quantification (LLOQ) in the range of 0.3-50.0 ng/mL, as well as high recovery percentages, indicating high bioanalytical applicability. The proposed method was efficiently applied to a pharmacokinetic evaluation of a fixed-dose combination of the analytes in healthy male volunteers.PMID:37114598 | DOI:10.1002/bmc.5664
Source: Biomedical Chromatography : BMC - Category: Biomedical Science Authors: Source Type: research