ISSN : 2663-2187

Analytical Quality by design (AQbD) approach: An advanced greener HPTLC method for Quantification of Lenvatinib in capsules

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Ms. Mona R. Patel, Dr. Harsha U. Patel
» doi: 10.33472/AFJBS.6.Si2.2024.1603-1616

Abstract

An Advanced and greener novel HPTLC method was developed based on Analytical Quality by design (AQbD) for the quantification of Lenvatinib in capsules. Chromatographic estimation of Lenvatinib was carried out utilizing TLC plate precoated with silica gel 60 F254 using mobile phase containing Toluene: Methanol in ratio of 8:2 and scanning at 245 nm. The developed HPTLC method of Lenvatinib was successfully validated according to ICH Q2(R1) guidelines with respect to linearity, accuracy, precision, robustness, Limit of Detection and Limit of Quantitation. Method optimization was carried out using three critical method parameters(CMPs), that is, Volume of organic phase(A), Saturation time(B) and band width(C). Box- benken design was applied to study the response surface methodology for analyzing of retention factor and peak area was considered as critical analytical attributes (CAAs). Interaction effects of CMPs and CAAs are evaluated using Design expert software version 12. The confirmation of significance (p<0.05) of the method parameters are measured using analysis of variance (ANOVA). The linear calibration curve of Lenvatinib in the concentration range of 100-1000 ng/band was obtained. The mean recoveries for developed method were found to be more than 99%. The % RSD for both inter- day and intra- day precision was less than 2%. The assay was found to be 99.80 ± 0.37%. The greenness score of the developed method was calculated utilizing the “Analytical GREENness(AGREE)” and “Green Analytical Procedure Index(GAPI)” approach. AGREE and GAPI score showing an excellent greenness characteristic of the present method. The detailed quantitative results showed that this method is novel, sensitive, eco-friendly as well as cost effective.

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