ABSTRACT

A Quality by Design (QbD)-driven (RP-HPLC) method was developed and validated for the estimation of piperine from Nilavembu Kudineer, a traditional Siddha formulation. The method was optimized using Box-Behnken design with flow rate, organic ratio in mobile phase, and injection volume as independent variables, targeting retention time and theoretical plates as responses. By performing the experiments as per the QbD concept the optimized mobile phase was identified as Acetonitrile and Water with 0.05% Acetic acid in the ratio of 45:55, through a Chromatopak C18 column (150?mm, 4.6 ×5??m), with a flow rate of 1 mL/min and UV detection at 342 nm. The optimized conditions yielded a retention time of 14.84 min and theoretical plates of 8851. Validation parameters demonstrated system suitability, excellent precision (% RSD 0.0009), linearity (R² = 0.999), robustness and sensitive detection (LOD 0.21 ?g/ml, LOQ 3.04 ?g/ml). This study provides a robust, reproducible analytical tool for quality control of piperine in herbal formulations. Keywords: QbD, RP-HPLC, Piperine, Nilavembu Kudineer, Herbal Formulations
Publication date: 01/06/2026

https://www.ijbpas.com/pdf/2026/June/MS_IJBPAS_2026_10243.pdf

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https://doi.org/10.31032/IJBPAS/2026/15.6.10243