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Issue: No. 94 (2026)
Section: Article
DOI: 10.58490/ctjump.2026i94.4400
Date Published: 25/01/2026
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Le, V. H. T., Huynh, H. P., Le, T. T. T., & Phan, T. D. (2026). DEVELOPMENT AND VALIDATION OF A METHOD FOR QUANTIFICATION CANDESARTAN RELATED COMPOUND IN CANDESARTAN AND ROSUVASTATIN TABLET. Cantho Journal of Medicine and Pharmacy, 94, 24-30. https://doi.org/10.58490/ctjump.2026i94.4400

DEVELOPMENT AND VALIDATION OF A METHOD FOR QUANTIFICATION CANDESARTAN RELATED COMPOUND IN CANDESARTAN AND ROSUVASTATIN TABLET

Van Hoai Tran Le1, , Hong Phuc Huynh2, Thi Thuong Thuong Le1, Thanh Dung Phan1
1 UMP Science and Technology Center, University of Medicine and Pharmacy at HCM City
2 School of Pharmacy, University of Medicine and Pharmacy at HCM City

Main Article Content

Abstract

 Background: Currently, some manufacturers are developing tablets containing the two active ingredients rosuvastatin and candesartan. However, neither major pharmacopoeias nor specialized journals have published any procedures for determining related impurities in such combination products. This study aims to develop and validate a procedure for quantifying candesartan-related impurities in tablets containing both rosuvastatin and candesartan, contributing to the establishment of quality control standards for this dual-ingredient formulation. Objectives: To develop and validate a method for the quantification of candesartan-related compounds in tablets containing both candesartan (as candesartan cilexetil) and rosuvastatin (as rosuvastatin calcium). Materials and methods: Related compounds A, B, D, F, and G (according to USP) of candesartan were investigated. A procedure was developed for simultaneous quantification of these five impurities in tablet containing two active ingredients, candesartan and rosuvastatin, using high-performance liquid chromatography (HPLC) with a photodiode array (PDA) detector, following the ICH Q2(R2) guideline. Results: Analytical conditions were as follows: Waters 2695e HPLC system equipped with a PDA detector and Empower 2 software; XBridge column C18 (250 × 4.6 mm, 5 μm, Waters); mobile phase consisting of acetonitrile and 0.05% phosphoric acid under a gradient program; flow rate of 1.0 mL/min; injection volume 10 μL; detection wavelength 254 nm. The analytical procedure met the requirements for system suitability, specificity, linearity, accuracy, and precision. Conclusions: A procedure for the quantification of five related impurities of candesartan in tablets containing both candesartan and rosuvastatin has been successfully developed and validated in accordance with ICH Q2(R2) guideline. 

Keywords

Candesartan cilexetil, candesartan related compounds, rosuvastatin calcium

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References

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