Determination of Tixocortol Pivalate by High-performance Liquid Chromatography

以高效液相層析法定量Tixocortol Pivalate

回德仁(Der-Zen Hwei) ； 葉明功(Ming-Kung Yeh)

《Journal of Medical Sciences》 14卷1期 (1993/08) Pp. 15-20

摘要

於水溶液，錠劑及噴鼻劑中，以逆相高壓液相層析法檢測tixocortol pivalate。本法以NOVA-PAK C18層析柱為固相，以氰甲烷及0.01 M pentanesulfonate混合液當移動相，調整酸鹼值於7.4下，用pentobarbital當内標準品，流速每分鐘1.5 ml，以紫外光檢測器波254 nm下，可得良好分離效果。其於模錠及水溶液中之回收率分為99.5％及99.7％，最大誤差小於1.0％，標準直線線性相關係數大於0.999。同時進行其於水溶液中之預安定性評估，發現其為擬一級次反應。

關鍵字

高效液相層析法 ； 品質管制

並列摘要

A simple and rapid HPLC method for the determination of tixocortol pivalate in solutions, tablets, and a nasal spray was developed. The separation was achieved on a NOVA-PAK C18 column with a mixture of acetonitrile and 0.01 M pentanesulfonate at pH 7.4 using pentobarbital as the internal standard. The flow rate was 1.5 ml/min and the UV detector with a nominal wavelength of 254 nm was used. Recoveries of tixocotrol pivalate form the model tablets and the solutions were 99.5 and 99.7%, respectively. The maximum error was less than 1.0%. Linear regression of the standard curve yielded a correlation coefficient greater than 0.999. The degradation of tixocotrol pivalate in aqueous systems was found to be in pseudo-first order. It is suggested that this HPLC method could be used for routine quality control assay of tixocotrol pivalate.

並列關鍵字

Tixocortol pivalate ； HPLC ； quality control