Establishment of a discrinatory dissolution method for orlistat capule and evalution of the similarity of dissolution curue / 中国药师

ABSTRACT

Objective To establish a discriminative dissolution test method for orlistat capsules and evaluate the similarity of dissolution curves of 6 domestic enterprises and imported orlistat capsules.Methods The HPLC method was used,the chromatographic column was Thermo Hyersil GOLD C18(150 mm×4.6 mm,5 μm)column,the mobile phase was acetonitrile and water(85∶15),the flow rate was 1.0 mL·min-1,the detection wavelength was 195 nm,the column temperature was 30℃,and the injection volume was 20 μL.The effects of different concentrations of sodium dodecyl sulfate,different concentrations of sodium chloride and different pH dissolution media on the dissolution curve were investigated,and the best dissolution conditions were selected.The similarity of the dissolution curve was evaluated using the dissolution curve similarity factor method.Results Orlistat had good linear relationship within the range of 5.989-179.697 μg·mL-1(r=0.999 8),and its average recovery rate was 100.4％,with an RSD of 1.1％(n=9).The optimal dissolution conditions selected were as follows:the pH 6.0 phosphate buffer solution containing 1.0％sodium dodecyl sulfate and 0.5％sodium chloride was as dissolution medium;the conduct dissolution tests conducted under conditions of paddle method,75 r·min-1 and medium 1 000 mL.Only one domestic enterprise had a similar dissolution curve between the product and the reference formulation,while the other five enterprises had inconsistent dissolution behavior between the product and the reference formulation.Conclusion This measurement method can effectively distinguish the dissolution behavior of products from different enterprises,and has certain reference significance to evaluate the consistency of the quality and efficacy of orlistat capsules in China.