薬事規制関連業務: オープンアクセス

パラセタモールおよびカフェインカプセルの投与量の同時推定のための UPLC 分析法の開発と検証

Abstract

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????????????????????????????????????325 mg ??? 30 mg????????????????????????????????????????????????????????UPLC????????????????UPLC ???2.1 × 50 mm??? C ₁₈????Acquity UPLC ???? ???? ???????BEH?C ₁₈ 1.7 μm???????????????????? A ??? 0.1% w/v H ₃ PO ₄??? 100% v/v ????????? B ?????????????????50:50??????????????????H ₃ PO ₄?80:20:0.1????????????????????????????????? 0.5 ml/?????????????????? PDA ??? (λ _max ) 275 nm ?????? 2 μL?????? 7 ?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????? ICH-Q2 (R1) ??? ICH-Q1C ??????????????