Analysis of the greenness to determine risperidone in commercial products using a green stability-indicating HPTLC method

Abstract

The purpose of this work was to develop and verify a green stability-indicating “high-performance thin-layer chromatographic (HPTLC)” technique to measure risperidone (RISP). The ternary mixture of ethanol, ethyl acetate, and ammonia (70:20:10 v/v/v) was the green mobile phase that was employed. At 281 nm, the detection of RISP was performed. The suggested method's greener profile was produced using the analytical eco-scale (AES), ChlorTox, and analytical GREENness (AGREE) methodologies. It was then contrasted with RISP analysis published HPTLC methods. The proposed methodology for measuring RISP in the 50–1400 ng/band range showed the linearity. Furthermore, the RISP measurement methodology was green, robust, precise (% RSD = 0.80–1.02), sensitive (LOD = 1.86 ng/band and LOQ = 5.60 ng/band), and accurate (% recoveries = 98.23–101.80). The AES, total ChlorTox, and AGREE scales for the suggested technique were found to be 83, 1.26 g, and 0.75, indicating an excellent greener profile. The current methodology's AES and total ChlorTox were significantly higher than those of previously published HPTLC RISP analysis methods. RISP was found to be highly stable under acid, base, and thermal stress conditions, while it was found to be most unstable under oxidative degradation conditions. Additionally, the stability-indicating aspect of the suggested technique was able to identify RISP in the presence of its degradation products. It was discovered that commercial tablet brands A and B had 98.12 and 99.62 % of RISP, respectively. The results of this investigation suggested that RISP in commercial formulations might be regularly analyzed utilizing the suggested green technology.

Keywords

• Green HPTLC
• Greenness tools
• Risperidone
• Stability-indicating method