LC-MS method for determination of olmesartan in human plasma

Abstract

Olmesartan belongs to a class of drugs called angiotensin II receptor blockers (ARBs). It works by relaxing blood vessels so that blood can flow more easily and is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Olmesartan medoxomil is an ester prodrug that is hydrolysed during absorption from gastrointestinal tract to the active form olmesartan. Due to rapid metabolism determination of the concentration of the prodrug in plasma is impossible. Previous human pharmacokinetic studies indicated that olmesartan is the only metabolite of olmesartan medoxomil. The aim of the study was to develop a method for the determination of olmesartan in human plasma. The developed LC-MS method is linear within the range of 5.00-2500.00 ng/mL which is suitable for pharmacokinetic studies after administration of 40 mg olmesartan medoxomil single oral dose. The sample preparation procedure is fast and allows examination of large numbers of samples in a short time. The method was validated according to European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines, in compliance with the principles of Good Laboratory Practice (GLP). All of the validation parameters met acceptance criteria and the method was successfully applied in the pharmacokinetic study in humans.

Validation of plasma amino acid profile using UHPLC-mass spectrometer (QDa) as a screening method in a metabolic disorders reference centre: Performance and accreditation concerns

“…Accordingly, different strategies have been tested, but no standard method has been defined and recognized by the various IEM societies or by the consortium of biologists. LC-MS has already shown potential in biological fluids (drug monitoring 22 , steroids 23 ). Conversely, hydrophilic interaction liquid chromatography (HILIC) allows faster analysis (15-20 minutes 24 ) but with low separation between leucine, isoleucine and alloisoleucine isobars 20 .…”

Recent developments in the chromatographic bioanalysis of approved kinase inhibitor drugs in oncology

“…Potentially, TKIs bound to erythrocytes could be freed during hemolysis [22][23][24][25][26][27]. This is discussed in the next section.…”

“…A possible concern in plasma analysis of TKIs is hemolysis. Several articles investigated the interference of hemolysis on matrix effect (ceritinib [22], dasatinib, sunitinib, imatinib, nilotinib, erlotinib, lapatinib, sorafenib, vandetanib [23]), precision and accuracy (sunitinib/N-desmethyl-sunitinib [24], lapatinib [25]), cross-talk, carry-over, and interference (imatinib [26,27]). They only tested spiking of either drug to hemolyzed plasma, hemolyzed blood to drug-containing plasma, or hemolytic blanks.…”

Modern Instrumental Methods for Qualitative and Quantitative Analysis of Lapatinib in Biological Fluids and Dosage Forms (Review)

“…Most of the assays described in the literature have been developed to detect and quantify lapatinib after high doses of the drug in daily clinical practice [30,[37][38][39]. The purpose of Musijowski J. et al study was to develop and validate a sensitive method of liquid chromatography in combination with a single quadrupole mass analyzer to determine lapatinib in human blood plasma [40]. This method is applicable for pharmacokinetics studies after a single oral dose of 0.25 g of lapatinib.…”