Determination of Rivaroxaban in Human Plasma by Solid-Phase Extraction–High Performance Liquid Chromatography

Abstract

In this study, a solid-phase extraction (SPE)-high performance liquid chromatography (HPLC)-ultra violet (UV) method was developed for the determination of rivaroxaban (RIV), an oral anticoagulant drug, in human plasma samples. The concentration of RIV in plasma samples was increased 7.5 times and the interference coming from matrix components was avoided by using SPE. The extracted samples of RIV were analyzed by using an HPLC-UV method. RIV was approved in 2008 and many studies have been published in recent years in order to investigate its pharmacokinetic profile in various groups. In light of this information, it is clear that the RIV pharmacokinetic profile should be investigated in further studies; the HPLC-UV method presented in this study might be an easy method to apply, as it is a cheap and rapid alternative to HPLC-MS-MS for this purpose. A Phenomenex Luna 5-µm C18 100 Å LC column (250 × 4.6 mm) was used for the separation of RIV and prednisolone (internal standard). The total analysis time was <6 min. The method was validated according to the FDA guidelines and can be proposed for pharmacokinetic studies of RIV.

DOAC plasma levels measured by chromogenic anti‐Xa assays and HPLC‐UV in apixaban‐ and rivaroxaban‐treated patients from the START‐Register

“…The six methods not supplemented with exogenous antithrombin showed LOD and LOQ values ranging from 3‐16 ng/mL and 8‐39 ng/mL, respectively, comparable to the available published data [LOD from 11 to 29 ng/mL (DiXaI‐HY, LRT‐HY, AntiXa‐STA) and LOQ from 6 to 52 ng/mL (DiXaI‐HY, LRT‐HY, AntiXa‐STA, AntiXa‐TC)] . The HPLC‐UV method showed good LOD and LOQ for apixaban and rivaroxaban (LOD from 5 to 9 ng/mL and LOQ from 16 to 29 ng/mL), comparable to values reported in literature (LOD from 4 to 5 ng/mL and LOQ from 10 to 19 ng/mL) …”

“…Among the analytical methods developed to quantify DOACs, HPLC‐UV has proven to be an easy, cheap, and rapid method for the quantitative measurement of DOACs, frequently available in clinical laboratories …”

“…High‐performance liquid chromatography method with ultraviolet detection (HPLC‐UV) has been developed and validated for the quantitative measure of apixaban, dabigatran, and rivaroxaban concentrations. Previous studies reported that it is a reliable and cost‐effective method, with a sensitivity around 10‐20 ng/mL, and it can be widely available in clinical laboratories …”

“…Previous studies reported that it is a reliable and cost-effective method, with a sensitivity around 10-20 ng/mL, and it can be widely available in clinical laboratories. [6][7][8][9] We conducted a multicenter study with the aim to investigate the performances of seven chromogenic anti-Xa assays with dedicated calibrators and controls and an HPLC-UV method for measuring apixaban and rivaroxaban plasma concentrations in patients engaged in the START-Register and treated with DOACs.…”

Spectrophotometric quantification of direct factor xa inhibitor, rivaroxaban, in raw and tablet dosage form

“…They include factor Xa specific chromogenic substrate assay [7], anti-Factor Xa chromogenic assay [8][9][10], prothrombin time assay [11], HPLC-MS/MS [12][13][14], HPTLC [15,16], HPLC [16][17][18][19][20][21][22][23][24][25][26] and UPLC [27]. The above reported methods suffer from drawbacks such as time consuming, cum bersome procedure, costly and require an expertise operational personal .…”