A Method for Eco-sustainable Quantification of 4-Hydroxy-3-Methoxy-Cinnamic acid in the Rhizome Extract of Alpinia galanga (L.) Willd., using Analytical Quality by Design Approach

Abstract

Introduction: A bioactive phenolic compound with considerable antioxidant and therapeutic potential, 4-Hydroxy-3-Methoxy-Cinnamic acid, also known as Ferulic Acid, is found in Alpinia galanga (L.) Willd. There are few UV-spectrophotometric methods based on Quality by Design (QbD) principles that show stability and are environmentally friendly.

Objectives: This study planned to design and validate a QbD-assisted, eco-friendly UV-spectrophotometric technique for 4-Hydroxy-3-Methoxy-Cinnamic acid measurement in the rhizome extract of Alpinia galanga (L.) Willd.,

Methods:

During method development and optimization, the environmentally friendly solvent system and a systematic QbD technique, method development and optimization were utilized. The method's stability-indicating characteristics were confirmed by investigation of forced degradation in acidic, alkaline, oxidative, thermal, and photolytic surroundings. Validation was completed following ICH Q2(R1) rules.

Results: Within a concentration range of 2–10 µg/mL, the method showed outstanding linearity (R² = 0.9997), with LOD and LOQ values of 0.920 µg/mL and 1.789 µg/mL, respectively. While precision tests showed %RSD less than 2%, the range of recovery values was 99.71% to 102.40%. In the rhizome extract of Alpinia galanga, 4-Hydroxy-3-Methoxy-Cinnamic acid's content was discovered to be 0.099 ± 0.003% w/w (n = 3). The method's environmental friendliness was confirmed by greenness assessment utilizing GAPI and AGREE.

Conclusion: The proposed UV-Spectrophotometric technique can be used  for phytochemical analysis and regular quality control of 4-Hydroxy-3-Methoxy-Cinnamic acid in the extract of Alpinia galanga (L.) Willd.,