article · Green Chemistry Letters and Reviews
An eco-friendly reversed-phase ultra-performance liquid chromatography method has been developed and validated to measure triamcinolone acetonide in a cream formulation. The approach replaces hazardous substances with greener alternatives to reduce laboratory waste, utilising a mobile phase of ethanol and purified water in a 30 to 70 ratio adjusted to pH 5.0. Experimental conditions were optimised using a Box-Behnken design to minimise test runs by evaluating the effects of ethanol ratio, pH levels, and flow rate on retention time, peak tailing, and theoretical plates. Analysis was conducted using a BEH C18 column at a detection wavelength of 240 nanometres. The resulting analytical method demonstrated strong linearity across a concentration range of 2.5 to 50 micrograms per millilitre and an accuracy recovery rate between 99.6 and 101.2 per cent. Method specificity was confirmed through forced degradation studies aligned with regulatory guidelines.
Standard pharmaceutical testing often relies on toxic organic solvents that generate hazardous chemical waste. Developing green analytical methods that use benign solvents such as ethanol and water helps pharmaceutical manufacturers reduce their environmental footprint. Validating these methods against degradation products ensures that eco-friendly alternatives can maintain strict regulatory standards for drug quality and safety testing.
This method is an applied and tested quality control procedure suitable for pharmaceutical manufacturers and analytical testing laboratories handling triamcinolone acetonide formulations. Because it has been validated in line with International Council for Harmonisation degradation standards and uses standard liquid chromatography equipment with common reagents, the protocol appears close to real-world adoption for routine commercial batch testing and stability analysis.
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A study on green analytical chemistry aims to develop eco-friendly alternatives to hazardous substances and minimize waste generation. The study thoroughly examined various tools to determine their greenness. A newly validated RP-UPLC method was then employed quantitatively to detect Triamcinolone Acetonide (TRA) in a creamy pharmaceutical formulation using UPLC BEH C18 (50 × 2.1 mm, 1.7μm) column for analysis, with a detection wavelength set at 240 nm. The Box-Behnken design was developed to efficiently determine the optimal chromatographic conditions while minimizing the required trials. The study effectively assessed the impact of three independent variables on various responses, including retention time, tailing factor, and theoretical plates. The variables examined ethanol ratio, pH levels, and flow rate were meticulously tested to optimize experimental conditions. The utilization of desirability and overlay plots, along with a mobile phase of ethanol and purified water in a volumetric ratio of 30:70 and pH adjustment to 5.0. Calibration curves were constructed to assess the linearity of TRA within the concentration range of 2.5-50 µg/mL, yielding correlation coefficients (r = 0.9999). The accuracy was validated through recovery studies with the acceptable range of 99.6-101.2%. The specificity of the method has been validated by conducting forced degradation studies per ICH guidelines.
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DOI: 10.1080/17518253.2023.2301315
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