エホニジピン塩酸塩およびクロルタリドン定量のための革新的な分析方法:重要なレビュー
Sejal Prajapati1, Kinjal Parmar2
1Department of Pharmaceutical Analysis, Parul Institute of Pharmacy and Research, Parul University, Vadodara, India.
Abstract:
A new fixed-dose combination of Efonidipine Hydrochloride Ethanolate (EFO) and Chlorthalidone (CHD) was approved by CDSCO in 2022 for the effective treatment of hypertension. While efonidipine is a dual L- and T-type calcium channel blocker, chlorthalidone is a thiazide-like diuretic. Numerous analytical techniques have been developed to enable accurate and dependable quantification in bulk, pharmaceutical dose forms, and biological matrices due to their combined therapeutic relevance. Several established analytical methods, including spectrofluorimetry, RP-HPLC, HPTLC, LC-MS/MS, NMR, and UV-visible spectrophotometry, are the main emphasis of this review. HPLC is the most widely used of these techniques because to its exceptional specificity and sensitivity. In accordance with the increasing focus on resilience, certain methods also include stability-indicating methods, such as Analytical Quality by Design, or AQbD. Eco-friendly techniques have also been shown to lessen the utilization of solvents and its detrimental impact on the environment. The document provides detailed information on chromatographic conditions, solvents, linearity, LOD/LOQ, detection wavelengths, and other important validation parameters. This review is a priceless tool for researchers and analysts working on pharmaceutical formulation development and quality control, as it assists them in selecting the most effective methods for routine EFO and CHD analysis. The review relies on peer-reviewed and reproducible data, explicitly stating that methods were sourced from scientific databases like Google Scholar, PubMed, and Elsevier's ScienceDirect, alongside official sources like the Indian and US Pharmacopoeias. The review does include studies published after the 2022 CDSCO approval of Efonidipine-Chlorthalidone. It cites several papers from 2024 and projected 2025, covering HPLC, HPTLC and eco-friendly methods specifically for this combination, confirming the review's current relevance to the approved FDCs.
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