Development and validation of an analytical method for the determination of nanostructured lipid carrier’s cinchonine used direct method modified by liquid-liquid extraction using high-performance liquid chromatography

Year 2023, Volume: 27 Issue: 2, 913 - 923, 27.06.2025

Hariyanti Hariyanti , Neng Fisheri Kurniati , Yeyet C Umirtapura Rachmat Mauludin

Abstract

Background: cinchonine nanostructured lipid carrier is a preparation with a nanoparticle lipid delivery
system. Analysis of levels (efficiency of entrapment) of cinchonine lipid nanostructure is critical to ensure the accuracy
of drug dosage. Objective: development and validation of an analytical method for the direct assay of nanostructured
lipid carrier’s cinchonine modified by liquid-liquid extraction using high-performance liquid chromatography.
Methodology: The research was started by determining the maximum wavelength and validation parameters of
selectivity, linearity, sensitivity, precision (intraday and inter days), accuracy, and assay (entrapment efficiency) of
nanostructured lipid carrier’s cinchonine directly with modification of liquid-liquid extraction. Results: maximum
wavelength of cinchonine 289 nm; selectivity (RF 4.096 ± 0.30 min and TF 1); linearity (R2) 0.9998; sensitivity (LoD 1.2016
mg/L and LoQ 4.0054 mg/L); precision (RSD intraday and RSD inter days <2%); accuracy (recovery 99.52 – 99.87%),
entrapment efficiency using direct assay of 94.85 ± 1.91% and indirect assay of 93.35 ± 0.22%. Conclusion: The analysis
method for the direct assay of nanostructured lipid carrier’s cinchonine modified by the liquid-liquid extraction method
using high-performance liquid chromatography is effective, efficient, and specific with high validity to determine the
concentration (entrapment efficiency) of cinchonine from nanostructured lipid carrier’s cinchonine.

Keywords

Cinchonine , Liquid-liquid extraction , Validation method , Nanostructured lipid carrier

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