Use of supercritical fluid extraction for sample preparation of sustained-release felodipine tablets.

Abstract:

: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.

journal_name

J Pharm Sci

authors

Howard AL,Shah MC,Ip DP,Brooks MA,Strode JT 3rd,Taylor LT

doi

10.1002/jps.2600831104

subject

Has Abstract

pub_date

1994-11-01 00:00:00

pages

1537-42

issue

11

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(15)49637-6

journal_volume

83

pub_type

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