JOURNAL ARTICLE

Simultaneous Estimation of Telmisartan, Chlorthalidone, Amlodipine Besylate and Atorvastatin by RP-HPLC Method for Synchronous Assay of Multiple FDC Products Using Analytical FMCEA-Based AQbD Approach.

  • Published In: Journal of Chromatographic Science, 2023, v. 61, n. 2. P. 160 1 of 3

  • Database: Academic Search Ultimate 2 of 3

  • Authored By: Prajapati, Pintu; Patel, Ankita; Shah, Shailesh 3 of 3

Abstract

This article focuses on the development and validation of a multipurpose reversed-phase high-pressure liquid chromatography (RP-HPLC) method for the synchronous assay of fixed-dose combinations (FDCs) containing telmisartan (TEL), chlorthalidone (CHL), atorvastatin calcium (ATO), and amlodipine besylate (AML). Employing an enhanced analytical quality by design (AQbD) approach—including failure modes critical effect analysis (FMCEA) and design of experiments (DoE) based on the Box–Behnken design—the method optimizes critical factors such as mobile phase composition, pH, and flow rate to achieve regulatory compliance with International Council for Harmonization (ICH) guidelines. The validated RP-HPLC technique uses a Shim-Pack octadecyl silane C18 column with an acetonitrile and triethylamine aqueous mobile phase, enabling accurate, precise, robust, and eco-friendly simultaneous quantification of these drugs in various FDCs under a single chromatographic condition. This method offers an economical and environmentally considerate alternative to existing assays that require separate chromatographic conditions for each FDC.

Additional Information

  • Source:Journal of Chromatographic Science. 2023/02, Vol. 61, Issue 2, p160
  • Document Type:Article
  • Subject Area:Religion and Philosophy
  • Publication Date:2023
  • ISSN:0021-9665
  • DOI:10.1093/chromsci/bmac030
  • Accession Number:161742917
  • Copyright Statement:Copyright of Journal of Chromatographic Science is the property of Oxford University Press / USA and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

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