Abstract
This study was aimed at developing a sensitive and selective HPLC method with postcolumn fluorescence derivatization for the detection of propylene glycol alginate sodium sulfate (PSS) in rat plasma. Plasma samples were prepared by a simple and fast ultrafiltration method. PSS was extracted from rat plasma with d-glucuronic acid as internal standard. Isocratic chromatographic separation was performed on a TSKgel G2500 PWxL column with the mobile phase of 0.1 M sodium sulfate at a flow rate of 0.5 mL/min. Analyte detection was achieved by fluorescence detection (FLD) at 250 nm (excitation) and 435 nm (emission) using guanidine hydrochloride as postcolumn derivatizing reagent in an alkaline medium at 120 °C. The calibration curve was linear over a concentration range of 1–500 μg/mL, and the lower limit of detection (LLOD) was found to be 250 ng/mL. This validated method was applied successfully to the pharmacokinetic study of PSS and PSS-loaded poly lactic-co-glycolic acid (PLGA) nanoparticles (PSS-NP) in rat plasma after a single intravenous (PSS only) and oral administration (PSS and PSS-NP). Significant differences in the main pharmacokinetic parameters of PSS and PSS-NP were observed. The relative bioavailability of PSS-NP was 190.10% compared with PSS which shows that PSS-NP can improve oral bioavailability.
Highlights
Cardiovascular and cerebrovascular diseases, encompassing coronary artery disease, heart failure, acute myocardial infarction, arrhythmias et al, are the most common causes of morbidity and mortality in the world [1]
Several attempts including the selections of columns, the fluorescence derivatization reagents and the internal standard (IS) were carried out to determine the analytes in plasma
The column selection was based on the properties of Propylene glycol alginate sodium sulfate (PSS) and relevant literature of similar polysaccharide drugs
Summary
Cardiovascular and cerebrovascular diseases, encompassing coronary artery disease, heart failure, acute myocardial infarction, arrhythmias et al, are the most common causes of morbidity and mortality in the world [1]. The average molecular weight of PSS is 11 KDa and the distribution width of the molecular weight is about 1.6. Systematic pharmacodynamics studies have shown that PSS has good anticoagulation, hypotensive activity, reducing blood viscosity and other functions [2]. PSS was first authorized for clinical applications in China in the 1980s. The routes of administration of PSS have been oral tablets and clinical intravenous injection. There are some side effects of PSS with intravenous administration [3]. The oral bioavailability of PSS is low due to poor absorption. A number of potential oral formulations of PSS have been developed to improve its oral bioavailability [4,5]
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