A New Liquid Chromatography-Tandem Mass Spectrometry Method for Determination of Bisoprolol in Human Plasma Samples

Abstract

Liquid chromatography (LC) coupled with mass spectrometry (MS) detection is one of the most powerful analytical tools for organic compound analysis. The advantages of using LC/MS methods over HPLC methods include: selectivity, chromatographic integrity, peak assignment, structural information, and rapid method development. In this paper, a new liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for the determination of bisoprolol in human plasma samples, using metoprolol as internal standard and liquid-liquid extraction procedure. The assay has proven to be sensitive, specific and reproducible, suitable to determine the bisoprolol concentration, following a single oral administration of a 10 mg bisoprolol tablet in 22 healthy volunteers, in the bioequivalence study of Bisoprolol 10 mg coated tablets, produced by Antibiotice S.A. versus Concor 10 mg, produced by Merck.

Forced degradation studies and structural characterization of related substances of bisoprolol fumarate in finished drug product using LC-UV-MS/MS

“…Chromatographic methods can be thin layer chromatographic, 2 and HPLC methods, [3][4][5][6][7][8][9][10][11][12][13][14] as well as ones that use HPLC with mass spectrometric detection especially for pharmacokinetic studies. [15][16][17][18][19][20][21] On the other hand, published data for determination of related substances of bisoprolol are limited, especially data on the characterization of its degradation products (DPs), which have been listed in European Pharmacopoeia as impurity A, B, C, D, E, F, G, K, L, N, Q, R, S, T and U. 22,23 There are several published studies developed for determination of related substances by using hydrophilic interaction liquid chromatography (HILIC) coupled with UV-DAD and MS detection 24,25 and a HPLC-MS study for characterization of one unspecified impurity in a finished drug product 26 for bisoprolol or in combination with amlodipine.…”

“…30,31 Information obtained during forced degradation studies gives data for both stability of the tested product and the suitability of the analytical method. 32 HPLC with UV detection is routinely used for quality control of finished drug products in pharmaceutical industry, [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] whereas mass spectrometry is used as an additional tool for structure elucidation of degradation products. 25,26,28,29 Often, the pharmacopoeial methods propose non-volatile mobile phase constituents and cannot be transferred to LC-MS. 22,23…”

A Novel Molecularly Imprinted Potentiometric Sensor for the Fast Determination of Bisoprolol Fumarate in Biological Samples

“…Several analytical techniques were available for the determination of the BF drug. These techniques include: spectroscopic techniques [3–10], chromatographic techniques [11–18], cyclic voltammetric and square wave voltammetric techniques (SWV) [19]. Most of these techniques are very expensive, require sample pre‐treatment, and required large quantities of not environmentally friendly organic solvents [20, 21].…”

First derivative synchronous spectrofluorimetric analysis of bisoprolol fumarate and ivabradine in pharmaceutical and biological matrices. Investigation of the method greenness

“…[15] The published literature revealed various analytical methods for the analysis of BSF such as spectrophotometry, [16][17][18] spectroflourimetry, [19] electrochemical methods, [20][21][22][23] HPLC, [24][25][26][27] and LC-MS/MS. [28] A combination of IVA and BSF is used for patients with stable angina and for patients with systolic heart failure that results in additional anti-ischaemic and antianginal effects. [29] To the best of our knowledge, no analytical methods have been documented for the simultaneous analysis of IVA and BSF.…”