QbD-Driven RP-HPLC Method Development and Validation for Trigonelline Quantification in Fenugreek Seeds and Phytosomal Formulation
1, 1, 1, 2
- 1Department of Pharmacognosy, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, INDIA.
- 2Department of Quality Assurance, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, INDIA.
CORRESPONDENCE
Akshay Kalgonda Patil
Department of Pharmacognosy, KLE College of Pharmacy, Belagavi, KLE Academy of Higher Education and Research (KAHER), Belagavi, Karnataka, INDIA.
Received: 23-03-2026; Accepted: 08-07-2026.
Volume 60, Issue 4s · pp. s1669-s1678 · 2026 · DOI: 10.5530/ijper.20262187
ABSTRACT
Background: Trigonelline is alkaloid known for its exceptional biological activities. The aim of the present work was to develop and validate Quality by Design based RP-HPLC method for estimation of trigonelline.Materials and Methods: The optimization process involves the design of experiments, utilizing response surface plots, contour plots, and overlay plots. The effective implementation of this method leads to a reduced retention time of 3 min, utilizing a reversed-phase C-18 column (5 mm, 4.6 mm, 250 mm, ZORBAX column). The mobile phase consists of methanol and water (40:60 v/v), with a flow rate of 1 mL/min at 265 nm.Results: The analytical technique has shown a linear response at 5-25 µg/mL, with R2=0.9994. The limits of detection and quantification were determined to be 0.425 µg/mL and 1.288 µg/mL, respectively, highlighting the sensitivity. Both precision assays, robustness and ruggedness demonstrated %RSD less than 2, indicating a reliable method. The accuracy was found to be 98.56% -99.76%, indicating the broad applicability. The established method was successfully employed to estimate the trigonelline content in fenugreek seeds and phytosomes with results showing 0.48% and 86.74%, respectively.Conclusion: This technique can be used to estimate trigonelline, for ensuring quality in phytopharmaceuticals.
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Patil, A. K., Teli, A. C., Gudasi, S. P., & Umarani, A. C. (2026). QbD-Driven RP-HPLC Method Development and Validation for Trigonelline Quantification in Fenugreek Seeds and Phytosomal Formulation. Indian Journal of Pharmaceutical Education and Research, 60(4s), s1669-s1678. https://doi.org/10.5530/ijper.20262187
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