RP-HPLC Method Development and Validation for Simultaneous Estimation of Withaferin A and Gliclazide in Herbal-Drug Combination Dosage Forms

Volume 23 No 8 (2025)

Shaik Munnisha Begam , Gope Edward Raju , Doonaboyina Raghava , Kavala Nageswara Rao

DOI: 10.48047/nq.2025.23.8.nq25017

Abstract

Withaferin A, a steroidal lactone derived from Withania somnifera (Ashwagandha), has shown promising antidiabetic properties. Gliclazide, a second-generation sulfonylurea, is widely used in type 2 diabetes management. The combination of herbal and allopathic agents is increasingly explored to achieve synergistic therapeutic benefits. This study aims to develop and validate a robust RP-HPLC method for the simultaneous estimation of Withaferin A and Gliclazide in combined herbal-drug formulations. Chromatographic separation was achieved using a C18 column with an optimized mobile phase of acetonitrile and phosphate buffer. The method was validated according to ICH Q2 (R1) guidelines and applied to in-house formulations, ensuring its reliability for routine quality control.

Keywords

RP-HPLC, Withaferin A, Gliclazide, herbal-drug combination, method validation, simultaneous estimation

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