Stability Indicating and Green Solvent-assisted Chromatographic Analysis of an Antiviral Drug

Abstract

This study presents a green chromatographic method for estimating the Ganciclovir, demonstrating validation parameters in alignment with ICH guidelines and green chemistry principles. The green analytical technique utilized the ethanol and acidic water at pH 3.0 as solvents, with an optimized mobile phase ratio of (80:20) and a flow rate of 1.0ml/min with a zorbax eclipse plus C18 (4.6 x 150mm, 5mm). Ethanol is listed as a green solvent in U.S Tri EPA with (CAS 64-17-5), as well as economical with manageable waste compared to traditional solvents. Green Evaluation tools such as AGREE, GAPI, and COMPLEX GAPI were employed to assess the greenness scores of the method. The AGREE tool provided an evaluation of the greenness of the method while the GAPI and COMPLEX GAPI offered details about the assessment of the method’s adherence to the green chemistry principles. These tools were developed in adherence to 12 green analytical chemistry principles that provide a holistic approach toward qualitative and quantitative evaluations. The importance of greenness in analytical methods lies in reducing environmental impact, improving analyst safety, lowering cost and waste, and fostering environmental responsibility. The linearity range was 10-50μg/ml with a regression coefficient of less than or equal to 0.999 indicating a strong linearship. RSD values are consistently below 2% and recovery rates for ganciclovir ranged from 98% to 102% within acceptable ranges. Under forced degradation conditions the desired amount of degradation was exhibited 8.02% degradation in acid, 9.25% in alkaline hydrolysis, 4.02% degradation in peroxide, 5.42 % in thermal, and 6.38 % in photolytic studies which are within limits as per 5-20% as per ICH Q1B guidelines. Incorporating ICHQ1(R2) the method validation parameters are within the range and thoroughly addressed.