Development and validation of stability indicating liquid chromatographic (RP-HPLC) method for estimation of ubidecarenone in bulk drug and formulations using quality by design (QBD) approach

A novel, accurate, precise and economical stability indicating Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method, was developed and validated for the quantitative determination of ubidecarenone (UDC) in bulk drug, UDC marketed formulation and UDC loaded cubosomes (CBMs) nanocarriers through Response surface methodology (RSM) design with three factors and three levels was performed to optimize the chromatographic variables followed by forced degradation studies of UDC were performed to detect degradation peak. RP-HPLC separation was achieved using mobile phase consisting of Acetonitrile:Tetrahydrofuran:Deionised water in the ratio 55:42:3 and a flow rate of 1.0 mL/min was optimized with a standard retention time (Rt) of 2.15 min, through experiment. The method was found linear in the concentration range of 5-100 µg/mL with a regression coefficient of 0.999. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 3.04 µg/mL and 9.11 µg/mL, respectively

FORMULATION AND EVALUATION OF NOVEL FLOATING IN SITU GELLING SYSTEM OF MACROLIDE ANTIBIOTIC USING DIFFERENT GELLING POLYMERS

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Recent patents and a market overview on green or bio-based solvents for chromatographic analysis: a review

Green solvents (GS) in chromatography originate from green chemistry. Therefore, using GSs in liquid chromatographic analysis to separate drugs and chemicals is an emerging approach to reduce hazardous chemicals in nature. The Orbit Intelligence database was used to conduct a strategic patent search for peer-reviewed patents on GSs as a mobile phase for chromatographic analysis. This article reported numerous approaches for encouraging GSs such as ethanol, butanol, esters, polyethylene glycol, supercritical fluids and nonionic surfactants to analyze drugs or compounds. The main aim of this article is to explore the patented GSs for chromatographic analysis and forecasting of the GSs that encourage industries to shift from hazardous to GSs. </jats:p

Additional file 1 of Fabrication of TPGS decorated Etravirine loaded lipidic nanocarriers as a neoteric oral bioavailability enhancer for lymphatic targeting

Additional file 1. An additional file for Supplementary Figures was provided in the supplementary section

Enhancing lymphatic uptake of Darunavir Ethanolate through TPGS-enriched lipid nanocarriers for oral delivery

Darunavir ethanolate (DRVE) is a promising molecule against wild-type protease inhibitors in human immunodeficiency virus (HIV) infection. It has a 37% oral bioavailability. In this study, the d-alpha-Tocopheryl Polyethylene Glycol 1000 Succinate (TPGS)-decorated DRVE-loaded lipid nanocarriers (DRVE-TPGS-LNCs) were optimized via central composite rotatable design using a modified solvent emulsification method. Various characteristic features of DRVE-TPGS-LNCs, such as globule size, polydispersity index, zeta potential, % entrapment efficiency, and % drug loading, were determined and found to be 116.5 ± 2.52 nm, 0.269 ± 0.0221, −10.8 ± 0.265 mV, 94.31% ± 10.75%, and 8.79% ± 0.937%, respectively. The spherical shape was evaluated by cryo-transmission electron microscopy. In-vitro study demonstrated % cumulative drug release of 81.70% ± 7.35% at pH 1.2 and 73.03% ± 7.17% at pH 6.8 after 12 h of drug release study. Moreover, the intestinal permeation and confocal microscope studies revealed approximately two-fold increased permeation in optimized nanoformulation across the gut sac compared to a drug suspension, and the inhibition of p-glycoprotein efflux was also confirmed by obtaining a minimum efflux ratio (0.253) of the optimized formulation compared to a drug suspension. The pharmacokinetic study demonstrated that the relative bioavailability of TPGS-DRVE-LNCs and drug suspension were found to be 19.85 ± 1.75 and 8.72 ± 0.753 μg.h/mL, respectively, which is approximately 2.25-fold more than the drug suspension which means approximately threefold increase in oral bioavailability compared to the drug suspension. The increased bioavailability in optimized DRVE-TPGS-LNCs was due to improved lymphatic uptake and p-glycoprotein efflux inhibition. Thus, the improved bioavailability of DRVE can meet the need to reduce the high dose of antiretroviral drugs to minimize the peripheral adverse reactions associated with the dose-related burden.</p