Box–Behnken design aided optimization and validation of developed reverse phase HPLC analytical method for simultaneous quantification of dolutegravir sodium and lamivudine co‐loaded in nano‐liposomes

Abstract

A stability‐indicating reversed‐phase high‐performance liquid chromatography method for simultaneous estimation of dolutegravir sodium and lamivudine encapsulated in the nanoliposomal formulation was developed. The chromatographic parameters namely, organic phase ratio, flow rate, and sample injection volume were selected as independent factors and were optimized by multivariate Box–Behnken design. Responses analyzed were retention time, peak area, and resolution. The optimized chromatographic method with Hypersil BDS C8 CN column as stationary phase and methanol and acetonitrile mixture and acidified Milli‐Q water (pH 2.8, adjusted with 0.02% v/v orthophosphoric acid) as the mobile phase in an isocratic elution mode was validated according to parameters of International Conference on Harmonization Q1(R2) guidelines. The validated reversed‐phase high‐performance liquid chromatography method exhibited specificity for both dolutegravir sodium and lamivudine in the presence of degradation products as well as the liposomal matrix. This method was effectively utilized to determine the amount of drug entrapped and drug loading efficiency of dolutegravir sodium and lamivudine in a nano‐liposomal formulation.

EN PRENSA. High Performance Liquid Chromatography coupled Diode Array Detector (HPLC-DAD) method development and validation for the quantification of triclosan in toothpaste. EN PRENSA

“…Para ello se optó por un diseño factorial fraccionado de Box-Behnken. Se ha demostrado que este DoE es un enfoque útil ampliamente aplicado en métodos analíticos para la optimización de las condiciones cromatográficas (Ahmad et al, 2016;Abril et al, 2018;Czyrski & Sznura, 2019;Mutalik et al, 2021;Alam et al, 2022), debido a que este diseño reduce sustancialmente la cantidad de experimentos necesarios para la optimización y, por lo tanto, ahorra tiempo y también considera las interacciones entre diferentes factores. Los usos prácticos del diseño de Box.Behnken para la estimación de fármacos como la pravastatina a granel y en forma de dosificación farmacéutica (Ahmad et al, 2016), determinación de contaminantes emergentes (incluido el TCS) en muestras ambientales (Abril et al, 2018), la cuantificación de antivirales en nanoliposomas cargados (Mutalik et al, 2021), y la estimación de fármacos naturales emergentes como la timoquinona de las semillas de Nigella sativa (Alam et al, 2022) han sido reportados previamente.…”

Novel experimental design paradigm for development of eco‐friendly gradient chromatographic method for simultaneous determination of metronidazole and spiramycin

“…Various experimental designs have been performed during the validation, development, and optimization of different analytical procedures [4][5][6][7][8][9][10][11][12][13][14][15][16]. Implementation of experimental designs has extended to the optimization of extraction procedures [17][18][19][20] and analysis of complicated mixtures and chiral separations [21][22][23].…”

Box‐Behnken assisted development and validation of high‐performance liquid chromatography method for the simultaneous determination of doxorubicin and vorinostat in polymeric nanoparticles

“…Non-specific toxicity and multiple drug resistance mainly limit the efficacy of both drugs [9]. Currently, the encapsulation of drugs into nanoformulations is widely used to improve the safety profile of drugs and overcome drug resistance [10,11]. In this work, we designed DOX-loaded (DOX-NP) and SAHA-loaded (SAHA-NP) nanoparticles based on a copolymer of lactic and glycolic acid (poly[lactic-co-glycolic acid], PLGA).…”