Quality by design (Qbd) approach to develop stability indicating HPLC method for estimation of rutin in chitosan-sodium alginate nanoparticles

Surendran Vijayaraj,Ponnusamy Rajavel,Kuppam Lathasri,Devalapalli Archana,Narahari N Palei

doi:10.1590/s2175-97902020000318793

Surendran Vijayaraj, Ponnusamy Rajavel + Show 3 more

Open Access

https://doi.org/10.1590/s2175-97902020000318793

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Abstract

Rutin is a flavonoid glycoside, mainly consists of phenolic compounds, responsible for many biological activities. The objective of the present study was to develop and validate a precise, simple, robust, rapid and reliable reverse phase high -performance liquid chromatography (RP-HPLC) technique by using Qbd approach for evaluating the rutin in nanoparticles. Central composite design (CCD) was employed for optimizing the experimental conditions of RP-HPLC method. Buffer pH, methanol content in the mobile phase composition, flow rate, and wavelength were selected as independent variables whereas retention time, peak area, and asymmetry factor was selected as dependent variables. The retention time, peak area and asymmetric factor of rutin by using optimized independent variables were found to be 3.75 min, 1014.79 mV, and 1.26 respectively. The limit of detection and limit of quantitation values were found to be 0.005 µg/mL and 0.15 µg/mL respectively. For confirming linearity, accuracy, precision, and robustness, the optimized assay condition was validated as per ICH guidelines. The proposed method, which was optimized by QbD approach was found to be a suitable method for analyzing the rutin in chitosan-sodium alginate nanoparticles.

Highlights

Rutin called as sophorin, rutoside and chemically (3,3,4,5,7-pentahydrohyf lavone-3-rhamnoglucoside) depicted in Figure 1 is a flavonoid glycoside and mainly consists of phenolic compounds, responsible for many biological activities (Janhvi, Sonali, Suryakant, 2014)
Quality by Design (Qbd) Approach to Develop Stability Indicating HPLC Method for Estimation of Rutin in Chitosan-Sodium alginate nanoparticles chromatographic separation of drugs was carried on an Inertsil C18 column reverse phase (250 mm×4.60mm, 5 μm particle size)
Response surface methodology (RSM) is used to analyse the problems associated with several independent variables and optimize the level of independent variables for obtaining the best systemic performance

Summary

Introduction

Rutin called as sophorin, rutoside and chemically (3,3,4,5,7-pentahydrohyf lavone-3-rhamnoglucoside) depicted in Figure 1 is a flavonoid glycoside and mainly consists of phenolic compounds, responsible for many biological activities (Janhvi, Sonali, Suryakant, 2014). Flavonoids represent a large class of phenolic compounds and largely distributed in plants such as vegetables, nuts, fruits, green seeds, tea, cocoa, soy and beverage products (Ahmad et al, 2017). Rutin (quercetin-3-O-rutinoside) was most abundant bioactive flavonoid called as vitamin P.

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