Supercritical fluid extraction of 13-cis retinoic acid and its photoisomers from selected pharmaceutical dosage forms.

摘要: Abstract 13- Cis retinoic acid (Accutane®) was extracted from a cream, gel, capsule and beadlet dosage form using supercritical carbon dioxide modified with 5% methanol as the mobile phase. The pump pressure extraction chamber restrictor temperature were experimentally optimized at 325 atm 45°C, respectively. A 2.5-min static 5-min dynamic time used. fluid (SFE) eluent trapped in methanol, injected into high-performance liquid chromatographic (HPLC) system, quantitated by ultraviolet detection 360 nm. Application of SFE method to spiked placebo forms gave cis recoveries 98.8, 98.9, 98.8 100% for beadlet, respectively, R.S.D.s range 0.6–0.9% ( n =4). Inter-day percent error precision 1.1–2.0 0.2–2.4% =3), intra-day 1.0–3.0 0.3–2.1% =8), Percent data celite samples 0.05–1.0 μg ml −1 0.59–4.75 1.8–2.1% applied commercial results compared unextracted samples. Linear regression analysis concentration versus peak height correlation coefficient 0.9991 slope 7.468 y -intercept 0.1923. 1.3–5.3 0.2–1.5% =4), photoisomers also 90.4–92.4% 1.5–3.4% obtained