Drug Release Method By HPLC for Orlistat Pellets 50%

DOI : http://dx.doi.org/10.13005/msri/050238

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In this study, a high performance liquid chromatography method was developed for the determination of orlistat with UV detection. The chromatographic system consisted of a Inertsil ODS 3V (5microns, 25?4.6mm) column, an isocratic mobile phase of Methanol, Acetonitrile and trifluroaceticacid (82.4:17.5:0.01).The flow rate is 1ml/minute and effluent is monitored at 210nm. Orlistat was eluted at about 6.0min with no interfering peak from excipients used for preparation of dosage form. The method was linear over the range of 10-150μg/ml orlistat (r^2>0.9999). The within-day and between-day precision values were also in the range of 0.182-0.265%. The appropriate dissolution conditions were also determined and applied to evaluate the dissolution profile of orlistat pellets. Based on the stability and basic nature of the drug, dissolution experiments were conducted in 1000ml of 0.1N Hydrochloric acid with 2%sodium lauryl sulphate with paddle stirring at 100 rotations per minute (rpm). Dissolution was found to be not less than 75% in 45. Dissolution medium and paddle at 100 rotation per minute. The proposed method was applied successfully to the determination of orlistat content in pellets and for in vitro dissolution studies.

Drug release; HPLC; orlistat pellets 50%