Asian Journal of Research in Chemistry
  • Year: 2024
  • Volume: 17
  • Issue: 4

A Review on Analytical Method Development and Validation of Flecainide using HPLC

  • Author:
  • Harsha Vasudev Chaudhari1,*, Javesh Kashinath Patil2, Devshree Yashwanthbhai Patel3, Aniket Rajesing Girase4
  • Total Page Count: 5
  • Published Online: Aug 8, 2025
  • Page Number: 250 to 254

1Department of Pharmaceutical Quality Assurance, P.S.G.V.P. M’s College of Pharmacy, Shahada, Dist. – Nandurbar, 425409

2Associate Professor, Department of Pharmaceutical Quality Assurance, P.S.G.V.P. M’s College of Pharmacy, Shahada, Dist. – Nandurbar, 425409

3Department of Pharmaceutical Quality Assurance, P.S.G.V.P. M’s College of Pharmacy, Shahada, Dist. – Nandurbar, 425409

4Department of Pharmaceutical Quality Assurance, P.S.G.V.P. M’s College of Pharmacy, Shahada, Dist. – Nandurbar, 425409

*Corresponding Author E-mail: harshavasudevc213@gmail.com

Online Published on 08 August, 2025.

Abstract

Analytical chemistry, the discipline focused on matter separation, identification, and quantification, encompasses traditional wet chemistry methods and modern instrumental approaches. Techniques like spectrophotometry and high-performance liquid chromatography (HPLC) are integral to analyte analysis. Spectrophotometry, particularly ultraviolet-visible (UV-Vis) spectroscopy, measures a sample’s absorption of uv and visible light, aiding in the determination of chemical concentrations in various fields. UV-vis spectroscopy operates on the principle that electron excitation in atoms and molecules, caused by UV and visible light absorption, results in quantized energy level transitions. HPLC, a type of column chromatography, separates, identifies, and quantifies substances based on their interactions with a stationary phase and a mobile phase. Key components of hplc include a column, pump, and detector, with separation efficiency influenced by the analyte’s interactions with the stationary phase. Method validation, as defined by ich q2 (r1), ensures that analytical procedures consistently yield reliable results. Critical validation criteria include specificity, accuracy, precision, linearity, range, limit of detection (lod), limit of quantification (loq), and robustness. Specificity confirms the method’s ability to measure the analyte accurately amidst other substances. Accuracy is assessed through recovery studies, while precision involves repeatability and reproducibility. Linearity and range ensure the method’s effectiveness across different concentrations. Lod and loq determine the method’s sensitivity. Robustness evaluates the method’s reliability under varying conditions. This review also examines flecainide acetate, a class ic antiarrhythmic agent, focusing on its analysis using hplc. Various studies highlight different mobile phases and columns used for flecainide’s analysis, emphasizing the importance of method optimization for accurate results. Flecainide’s mechanism involves inhibiting sodium channels, extending the heart’s refractory period, and reducing calcium release from the sarcoplasmic reticulum, showcasing its significance in treating arrhythmias.

Keywords

Analytical Chemistry, UV-Vis Spectroscopy, High-Performance Liquid Chromatography (HPLC), Method Validation, Flecainide Acetate