Use of supercritical fluid extraction for sample preparation of sustained-release felodipine tablets.
Supercritical fluid extraction (SFE) was shown to be an accurate and precise alternative to liquid extraction for sample preparation of sustained-release felodipine tablets (5 mg potency) while realizing an 80% reduction in solvent consumption. Extractions of felodipine spiked on an inert support were used to evaluate the solubility of felodipine in CO2 as well as analyte trapping after SFE. Even though the pure drug was found to be soluble in pure CO2, extractions of felodipine from the tablet matrix required moderate modifier concentrations [8.7% (v/v) methanol in CO2] in order to overcome strong matrix-drug interactions. Sequential static/dynamic extraction steps were also required to quantitatively recover the drug from the tablet matrix, indicating that the drug extraction was diffusion-limited. Average recoveries (n = 5) for the optimized SFE method were determined to be 4.93 mg felodipine tablet (98.6% claim) with an RSD of 1.2% versus those for the liquid extraction procedure (n = 5, 4.98 mg/tablet, 99.6% claim, 2.4% RSD). Similar levels of drug degradation (0.12% expressed as felodipine) were also obtained with both the traditional liquid extraction and with the SFE method.
Howard
A L
AL
Merck Research Laboratories, West Point, PA 19486.
Shah
M C
MC
Ip
D P
DP
Brooks
M A
MA
Strode
J T
JT
Taylor
L T
LT
D002851:Chromatography, High Pressure Liquid; D003692:Delayed-Action Preparations; D015736:Felodipine / Q000008:administration & dosage / Q000032:analysis*; D013056:Spectrophotometry, Ultraviolet
D003692:Delayed-Action Preparations; D015736:Felodipine