Development and validation of an enhanced resource efficient high performance liquid chromatography (HPLC)- evaporative light scattering detector (ELSD) method for determination of inulin in pharmaceutical formulations

A simple, rapid, and robust high-performance liquid-chromatography method coupled with evaporative light scattering detector (ELSD) was developed and validated in accordance with ICH Q2 (R2) guidelines for identifying inulin from pharmaceutical formulations. The existing methods are not only time-consuming but also require the compound to be hydrolyzed into monosaccharide prior to detection. This process eliminates the need for extensive sample preparation allowing for immediate detection. Chromatographic separation was achieved using a C18 reverse phase column (4.6 × 100 mm, 3.5 mm) with an isocratic regime along with water/methanol (80:20) as a mobile phase. Inulin was eluted at a retention time of around 2.4–2.6 min without pre-treatment. The method demonstrated good linearity over a concentration range of 10–80 μg/mL with a correlation coefficient (R 2 ) of 0.998. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 10.41 and 31.57 μg/mL respectively. The method was further validated for suitability and greenness assessment using various metrics and found to show resource efficient and sustainable profile. The validated methodology was successfully applied for the analysis of inulin from inulin acetate tablets after in vitro release study. The proposed technique eliminates the need for extensive sample preparation and hydrolysis steps and enables direct detection of inulin. Overall, the developed HPLC-ELSD method can be regarded as a simple, easy, reliable, sustainable and cost-effective for routine quality control or analysis of inulin and its derivative in pharmaceutical dosage forms. • Inulin is a non digestible fiber with an exceptional nutritional value. • Since it lacks a chromophore, it can't be analyzed using conventional techniques. • A novel method for its detection/quantification using HPLC-ELSD has been developed. • Further validation study of the method was performed following ICH guidelines. • Allows for immediate detection without extensive sample preparation steps.