Validated HPLC Method for Simultaneous Estimation of Candesartan and Nifedipine in Hypertension Combination Therapy: Optimization through DoE

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Darshil B. Shah
Bhavesh H. Patel
Jignesh S. Shah


Introduction: Hypertension poses significant health risks globally, necessitating effective management strategies. Combination therapy, such as Candesartan and Nifedipine, shows promise in improving treatment outcomes. However, analytical challenges in simultaneous estimation underscore the need for advanced techniques.

Methods: A Design of Experiment (DoE) based High-Performance Liquid Chromatography (HPLC) method was developed to optimize chromatographic conditions. Candesartan and Nifedipine samples were analyzed using reversed-phase HPLC with UV-Vis spectrophotometry detection. Statistical analysis and response surface methodology aided in method optimization.

Results and Discussion: Optimal chromatographic conditions were achieved with a composite mobile phase and specific parameters. The Central Composite Design (CCD) facilitated efficient experimentation, yielding robust models for retention time and tailing factor. Validation studies demonstrated specificity, linearity, precision, accuracy, and system suitability of the method.

Conclusion: The developed HPLC method offers accurate and efficient quantification of Candesartan and Nifedipine in combination therapy for hypertension management. Validation studies confirm the method's reliability and accuracy, highlighting its potential for routine analysis and quality control in pharmaceutical formulations.

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