RP-HPLC Method Development and Validation for Simultaneous Estimation of Vitamin D3 and Alendronate in Combined Dosage Forms Used for Osteoporosis

Volume 23 No 8 (2025)

Tatipaka Anusha , Gope Edward Raju , Doonaboyina Raghava, Kavala Nageswara Rao

DOI: 10.48047/nq.2025.23.8.nq25018

Abstract

Osteoporosis therapy often involves the concurrent administration of Vitamin D3 and bisphosphonates such as Alendronate to enhance bone mineralization and reduce fracture risk. However, the simultaneous formulation of these drugs poses challenges due to their differing physicochemical properties. This study aims to develop and validate a reverse-phase HPLC method for the simultaneous estimation of Vitamin D3 and Alendronate in pharmaceutical combinations. The method is optimized for adequate separation, peak resolution, and quantification, and validated according to ICH guidelines. The developed method can aid in the quality control of dual-component formulations and support pharmaceutical development.

Keywords

RP-HPLC, Vitamin D3, Alendronate, Simultaneous Estimation, Osteoporosis, Method Validation

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