Development and validation of an analytical method by RP-HPLC for quantification of sibutramine hydrochloride in pharmaceutical capsules

[摘要] Sibutramineisamonoaminere-uptakeinhibitorusedforthetreatmentofobesity.Inthepresentstudyarapid,sensitiveandeconomicalHPLCmethodwasdevelopedandfullyvalidatedforanalysisofsibutramineHClinpharmaceuticalcapsules.HPLCanalyseswerecarriedoutbyusinganisocraticelutionmodewithamobilephaseconstitutedbysodiumphosphatebuffer(pH2.5)andmethanol(30 : 70,v/v),flowrateat1.0mLmin−1,columntemperatureat40°C,UVdetectionwavelengthat225nmand20µLofinjectionvolume.ThevalidationparameterswereinaccordancewithFDAandICHspecifications,showingaccuracy,precision,selectivity,robustnessandlinearityfrom4.5to19.5mgL−1ofsibutramineHCl.Thelimitsofdetectionandquantificationwere0.666and2.018mgL−1,respectively.Thevalidatedmethodissuitableforqualitycontrolapplicationsanditsadvantagesoverthealreadyexistingmethodsaresimplicityandreducedanalysistime...

[学科分类] 分析化学