Development And Validation Of A Sensitive Bioanalytical LC-MS/MS Method For Simultaneous Estimation Of Bisoprolol Fumarate And Cilnidipine In Human Plasma
Year: 2026
Type: article
Abstract: A highly sensitive, selective and robust LC-MS/MS bioanalytical technique was designed and tested to simultaneously determine Bisoprolol Fumarate (BISO) and Cilnidipine (CIL) in K2EDTA human plasma. Chromatographic separation was achieved using a Sapphirus C18 HP Classic column (150 × 4.6 mm, 5 µm) with a mobile phase consisting of 10 mM ammonium acetate and methanol (10:90, v/v). The detection of each analyte was performed using turbo ion spray (TIS) in positive ion mode with Multiple Reaction Monitoring (MRM). Benidipine hydrochloride was taken as an internal standard (ISTD). Preparation of the sample was performed through liquid-liquid extraction (LLE). The method was validated according to ICH M10 guidelines over the concentration range of 0.2–40 ng/mL for Bisoprolol fumarate (correlation coefficients (R2 ): 0.9993) and 0.1–20 ng/mL for Cilnidipine (correlation coefficients (R2 ): 0.9999). The method met all regulatory acceptance criteria for precision, accuracy, recovery, matrix effect, dilution integrity, and stability. The validated method is suitable for application in pharmacokinetic studies, as well as bioavailability and bioequivalence assessments.
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W7161401799