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Simultaneous determination of ezetimibe, atorvastatin and simvastatin using quadrupole LC-MS: Application to combined tablets and plasma after SPE

Elawady Tarek, Ibrahim Fawzia, Khedr Alaa, Belal Fathalla

Acta Chromatographica

2021

Vol. 33, no. 3

245--252

A simple and sensitive liquid chromatography-mass spectrometric (LC-MS) method has been developed and validated for the simultaneous determination of ezetimibe (EZE), atorvastatin calcium (ATO), and simvastatin (SMV) in combined dosage forms and human plasma. Successful separation of the studied drugs was achieved on a Zorbax Eclipse Plus C18 column (3.0 × 150 mm, 5 µm) using a mobile phase consisting of acetonitrile and 0.1% formic acid in water (65:35, v/v) at a flow rate of 0.5 mL min-1. Total run time was 9.3 min and diclofenac sodium was used as internal standard (IS). Positive selected ion monitoring (SIM) mode was applied where, the monitored ions were those at m/z values of 392.1, 559.3, 296.0, and 441.4 corresponding to EZE, ATO, IS, and SMV, respectively. The method was fully validated according to the ICH guidelines. The intraday and interday precision showed relative SD values not more than 1.77 and 1.99%; respectively. The limits of detection (LOD) were 0.25, 0.25, and 0.75 ng mL-1 while the limits of quantification (LOQ) were 1.25, 0.75, and 2.5 ng mL-1 for EZE, ATO, and SMV, respectively. The developed method was applied on two types of combined tablets concerning drug assay with mean percent recoveries within acceptable range. The method has been extended to the determination of the studied drugs in human plasma where, a solid phase extraction method was optimized for their extraction with percent recovery not less than 97%.

Wysokosprawne metody rozdzielania ze specyficzną detekcją — spektrometrią mas — w bionieorganicznej analizie specjacyjnej

Połeć-Pawlak K., Mojski M., Jarosz M.

Chemia i Inżynieria Ekologiczna

2002

Vol. 9, nr 10

1135--1155

Przedstawiono rozwój wysokosprawnych metod rozdzielania połączonych ze spektrometrem mas — czułymi selektywnym detektorem, które znalazły szerokie zastosowanie w bionieorganicznej analizie specjacyjnej. Omówiono połączenia chromatografii cieczowej i elektroforezy kapilarnej ze spektrometrem mas z jonizacją elektrorozpraszającą (ES MS) i w plazmie indukcyjnie sprzężonej (ICP MS). Przedstawiono wady i zalety poszczególnych rozwiązań, a także najpowszechniejsze problemy pojawiające się w pracy z metodami sprzężonymi.

An overview of recent evaluation in the coupling of high efficiency separation techniques with mass spectrometry detectors is presented, with special emphasis placed on the speciation analysis in bioinorganic chemistry. Examples of different interfaces of liquid chromatography and capillary electrophoresis mainly with mass spectrometry with ionization in electrospray and ionization in plasma (inductively coupled plasma mass spectrometry — ICP MS) are described following its development according to the used micro-concentric nebulizer. Characteristic of interfaces was carried with discussion of the method's strengths and limitations as a consequence of different technical solutions in presented couplings. It is intended to provide some guidelines to those researches first exposed to this important and powerful technique in speciation analysis.