薬事規制関連業務: オープンアクセス

シプロフロキサシン点眼薬中の防腐剤ベンザルコニウム塩化物の分析法開発と検証

Abstract

???? S??????? MD???????? MD????? ???? MD?????????? MD*

????????????????????????????????????????????????? HPLC ????????????????????????????? (PH 5.5) ???????? (40:60?v/v) ?????????????????L10 ??? (??: 15 cm × 4.6 mm?????? 5 µm) ?????????????????????? 1 mL/?? 210 nm ???????? (R2) ? 0.999 ?????????????? 50% ????? 0.05?0.08?0.10?0.12?0.15 mg/mL ?????????????????????????-1 ???????????-2 ?????????? 5.965 ?? 6.993 ?????????????????????????????????????????????????? (ICH) ?????????????????????????????????????????????????????????