Determination of betamethasone disodium phosphate in the in vitro media of PLGA microspheres by high-performance liquid chromatography.
Betamethasone disodium phosphate is a kind of corticosteroid, which is commonly used in the intralesional treatment of keloids. In this work, polymeric microspheres loaded with betamethasone disodium phosphate were fabricated to design a sustained-release system. A validated HPLC technique for determination of betamethasone disodium phosphate in in vitro media of the polymeric microspheres has been developed. The operation conditions were optimized. The analytical column was ZORBAX Bonus-RP column with 4.6 x 150 mm ID and a particle size of 5 microm. The mobile phase consisted of acetonitrile-0.01% phosphoric acid water solution (40:60, v/v). The flow rate was 1.0 ml/min and injection volume was 50 microl. The elutes were detected at 240 nm. Linearity, repeatability, inter- and intra-assay precision and accuracy of the method were evaluated. The liner range was obtained in a concentrated range of 20-1000 microg/ml, with a coefficient of correlation r=0.999978. The limit of detection for betamethasone disodium phosphate in the in vitro test samples was 0.25 microg. Recovery of betamethasone disodium phosphate from the in vitro test samples was 99.7+/-5.2% (mean+/-SD). Stability of betamethasone disodium phosphate at different pH values and temperatures were also investigated.
Wang
Ling
L
Institute of Materials Research and Engineering, No. 3 Research link, Singapore 117602, Singapore.
Yang
Yi Yan
YY
Chung
Tai Shung
TS
Chen
Xue Qin
XQ
D000893:Anti-Inflammatory Agents / Q000032:analysis*; D001623:Betamethasone / Q000032:analysis*; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D005079:Excipients; D006863:Hydrogen-Ion Concentration; D019344:Lactic Acid; D013058:Mass Spectrometry; D008863:Microspheres; D011100:Polyglycolic Acid; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011108:Polymers; D012015:Reference Standards; D015203:Reproducibility of Results
D000893:Anti-Inflammatory Agents; D005079:Excipients; D011108:Polymers; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid; D001623:Betamethasone