DEVELOPMENT AND VALIDATION OF HPLC/PDA METHOD FOR THE SIMULTANEOUS DETERMINATION OF AMLODIPINE BESYLATE, TELMISARTAN AND INDAPAMIDE
Main Article Content
Abstract
Background: In June 2025, the United States Food and Drug Administration approved the original brand-name product WIDAPLIK, the first and only fixed-dose triple combination containing telmisartan, amlodipine and indapamide for the treatment of hypertension. This combination not only enhances therapeutic efficacy but also significantly improves patient adherence. Currently, pharmacopeial references provide analytical procedures for single or dual combinations; however, no monograph is available for the simultaneous quantification of these three components in a single formulation. In the context of the anticipated increase in the development of corresponding generic products in Vietnam, validated analytical procedures are essential for quality control. Objectives: To develop and validate an HPLC/PDA method for the simultaneous quantification of amlodipine, telmisartan and indapamide in accordance with ICH guidelines. Materials and methods: Simulated samples containing amlodipine, indapamide and telmisartan were analyzed. Results: The optimized HPLC/PDA conditions employed a Reliant C18 column (250 × 4.6 mm; 5 µm) with an isocratic mobile phase consisting of acetonitrile and buffer (0.025 N KH₂PO₄, pH 3.0) in a ratio of 45:55 (v/v), at a flow rate of 1.0 mL/min and detection wavelength of 242 nm. The method demonstrated good specificity. The linear concentration ranges were 10.17 – 28.48 µg/mL for amlodipine, 5.04 – 14.12 µg/mL for indapamide, and 80.87 – 226.44 µg/mL for telmisartan. Recoveries ranged from 98.0% to 102.0%. The intra-day and inter-day precision (RSD) were 1.29% – 1.33%, 1.98% – 1.80%, and 1.28% – 0.77% for amlodipine, indapamide, and telmisartan, respectively. The analytical procedure met the requirements for robustness. Conclusions: The developed HPLC/PDA method for the simultaneous quantification of amlodipine, indapamide, and telmisartan meets ICH validation requirements and is suitable for quality control of pharmaceutical formulations.
Keywords
Amlodipine, telmisartan, indapamide, HPLC
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References
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