Determination of cilostazol and its active metabolite 3,4-dehydro cilostazol from small plasma volum

来源 :Journal of Pharmaceutical Analysis | 被引量 : 0次 | 上传用户:bodden
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A simple,rapid and sensitive ultra performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS) method has been developed for the simultaneous determination of cilostazol and its pharmacologically active metabolite 3,4-dehydro cilostazol in human plasma using deuterated analogs as internal standards(ISs).Plasma samples were prepared using solid phase extraction and chromatographic separation was performed on UPLC BEH C_(18)(50 mm × 2.1 mm.1.7 μm) column.The method was established over a concentration range of 0.5-1000 ng/mL for cilostazol and 0.5-500 ng/mL for 3.4-dehydro cilostazol.Intra- and inter-batch precision(%CV) and accuracy for the analytes were found within 0.93-1.88 and 98.8-101.7% for cilostazol and 0.91-2.79 and 98.0-102.7% for the metabolite respectively.The assay recovery was within 95-97% for both the analytes and internal standards.The method was successfully applied to support a bioequivalence study of 100 mg cilostazol in30 healthy subjects. A simple, rapid and sensitive ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS / MS) method has been developed for the simultaneous determination of cilostazol and its pharmacologically active metabolite 3,4-dehydro cilostazol in human plasma using deuterated analogs as internal Standards (ISs). Plasmids were prepared using solid phase extraction and chromatographic separation performed on UPLC BEH C_ (18) (50 mm × 2.1 mm.1.7 μm) column. The method was established over a concentration range of 0.5-1000 ng / mL for cilostazol and 0.5-500 ng / mL for 3.4-dehydro cilostazol.Intra- and inter-batch precision (% CV) and accuracy for the assays were found within 0.93-1.88 and 98.8-101.7% for cilostazol and 0.91-2.79 and 98.0-102.7% for the metabolite respectively. The assay recovery was within 95-97% for both the analytes and internal standards. the method was successfully applied to support a bioequivalence study of 100 mg cilostazol in 30 healthy subjects.
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