Division of Pharmaceutics & Pharmacokinetics, CSIR-Central Drug Research Institute, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow 226031, U.P, India.
Jawaharlal Nehru University (JNU), New Delhi 110067, India.
Bioanalysis. 2024 Jun 2;16(11):557-567. doi: 10.1080/17576180.2024.2344395. Epub 2024 Jul 16.
A HPLC method was developed and validated for the novel combination of rutin (RN) and donepezil (DNP). RN and DNP were simultaneously eluted through a C18 column (Ø 150 × 4.6 mm) with a 60:40 v/v ratio of 0.1% formic acid aqueous solution to methanol at 0.5 ml/min. The purposed method was found linear, selective, reproducible, accurate and precise with percent RSD less than 2. The limit of quantification for RN and DNP was found 3.66 and 3.25 μg/ml, respectively. Validated as per the ICH guidelines, the developed method efficiently quantified RN and DNP co-loaded in DQAsomes (121 nm) estimating matrix effect, release profile, entrapment efficiency, loading efficiency and plasma kinetics.
建立并验证了一种高效液相色谱法，用于同时测定芦丁（RN）和多奈哌齐（DNP）的新组合。RN 和 DNP 通过 C18 柱（Ø 150×4.6mm）以 0.1%甲酸水溶液与甲醇 60:40（v/v）的比例，以 0.5ml/min 的流速洗脱。所提出的方法线性、选择性、重现性好，准确度和精密度高，RSD 小于 2%。RN 和 DNP 的定量下限分别为 3.66 和 3.25μg/ml。根据 ICH 指南进行验证，该方法可有效定量 DQAsomes（121nm）中同时负载的 RN 和 DNP，评估其基质效应、释放曲线、包封效率、载药效率和血浆动力学。
