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Abstract

The pharmaceutical industry has brought advancement and opportunities. However, it has also presented challenges and complexity that must be addressed. The pharmaceutical industry aims to protect public health by providing economical, effective, safe, and appropriate treatments. The analytical method monitors medication concentrations to ensure efficacy and safety. Chemical preservations protect drugs from microbes until administration. In Refax suspensions, the concentration of rifaximin (Antibacterial, API) and sodium benzoate (chemical preservative) must be determined to ensure the suspension's effectiveness, stability, and safety with regulatory standards.

An innovative HPLC method was created to monitor the concentrations of rifaximin (Antibacterial, API) and sodium benzoate in the Refax Suspension. It was performed by running a mobile phase consisting of a methanol and phosphate buffer on a stationary phase of a C18 column (BDS Hypersil, Thermo Scientific) at a 1 ml min-1 flow rate. The detector was adjusted at 230 nm. The optimized method was validated following the ICH guidelines. It was approved to be linear in the range of 25-200 and 2-16 μg mL-1, achieving good accuracy results in 99.68% and 99.71% with high sensitivity in terms of LOD concentrations (0.2 and 1.8 μg mL-1) for Sodium benzoate and Rifaximin, respectively.

To achieve the objective of conserving public health, the innovative HPLC method's green evaluation combines a variety of tools, including the analytical greenness metric (AGREE), Green Analytical Procedure Index (GAPI), and ECO Scale. The optimized method revealed acceptable results in green assessment.

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