Simultaneous estimation of rutin and donepezil through RP-HPLC: implication in pharmaceutical and biological samples

Abstract

Aim: A HPLC method was developed and validated for the novel combination of rutin (RN) and donepezil (DNP). Materials & methods: 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. Results: 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. Conclusion: 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 in vivo plasma kinetics.

GRAPHICAL ABSTRACT

Summary points

• A simple, robust and economical RP-HPLC method was developed to simultaneously estimate rutin (RN) and donepezil (DNP) and validated as per International Conference of Harmonization (ICH) regulatory guideline.

• The limit of detection (LOD) was found to be 1.209 μg/ml and 1.074 μg/ml, while the Limit of Quantification (LOQ) was found to be 3.664 μg/ml and 3.257 μg/ml for RN and DNP, respectively.

• Artificial cerebrospinal fluid (ACSF) matrix showed ion suppression for both RN and DNP whereas dequalinium (DQA) as formulation matrix demonstrated ion suppression for RN and ion enhancement for DNP.

• RN and DNP co-loaded DQAsomes was prepared and estimated for loading efficiency, entrapment efficiency, release profile and plasma kinetics providing practical implication of developed method in both pharmaceuticals and biological samples.

Keywords: :

• donepezil
• DQAsomes
• HPLC
• PKSolver
• rutin
• simultaneous estimation

Supplemental material

Supplemental data for this article can be accessed at https://doi.org/10.1080/17576180.2024.2344395

Financial disclosure

The authors have no financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, stock ownership or options and expert testimony.

Writing disclosure

No writing assistance was utilized in the production of this manuscript. This is CSIR-CDRI communication 10776.