HPLC Analysis of Orlistat and Its Application to Drug Quality Control Studies

概要

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In this study, a high performance liquid chromatography method with UV detection was developed for determination of orlistat. The chromatographic system consisted of a Nova-Pack C_<18> column, an isocratic mobile phase of phosphoric acid 0.1%-acetonitrile (10: 90, v/v) and UV detection at 205nm. Orlistat was eluted at about 6min with no interfering peak from excipients used for preparation of dosage form. The method was linear over the range of 10-160μg/ml orlistat (r^2>0.9999). The within-day and between-day precision values were also in the range of 0.10-0.59%. The appropriate dissolution conditions were also determined and applied to evaluate the dissolution profile of orlistat capsules. Optimal conditions were 1000ml of 3% SLS in water as dissolution medium and paddle at 100 rotation per minute. The proposed method was applied successfully to the determination of orlistat content in capsules and in vitro dissolution studies.
公益社団法人日本薬学会の論文
2007-02-01