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Stability-Indicating Greener UV Spectrophotometric Method for Felodipine Assay in Pharmaceutical and Urine Samples and Comprehensive Degradation Studies with IR Spectral Analysis
Abstract
A stability-indicating greener UV spectrophotometric method was developed and is here reported to quantify felodipine (FDP) in pharmaceutical and spiked human urine samples, with degradation studies and IR spectral analysis of degradation products. The approach involved the preparation of calibration curves using varying concentrations of FDP in 1:1.5 acetic acid (HOAc) and measuring absorbance at 365 nm. Relative standard deviation (RSD) values for the synthetic mixture were less than 5%, and the recovery rate of FDP ranged from 95.65 to 103.1%. The FDP showed considerable degradation under basic conditions, as indicated by a shift in the λmax, a decrease in recovery at the analytical wavelength, and changes observed in the IR spectrum. The method's robustness and ruggedness were confirmed through variations in experimental conditions and reproducibility tests, with RSD values between 3 and 5%. In the analysis of spiked human urine samples, the method demonstrated high recovery rates of FDP, ranging from 95.50 to 102.30%, with RSD values below 5%, confirming its applicability to analyse physiological samples. The method showed excellent linearity over 2.5–100 µg/mL FDP, low limits of detection (0.86 µg/mL), and quantification (2.62 µg/mL), with the regression coefficient (r) of 0.9983, making it suitable for routine analysis of FDP in pharmaceutical formulations and clinical samples. This method provides a reliable approach to quantify FDP, with a proven stability-indicating capability, and applies to both pharmaceutical and physiological contexts. The developed method is environmentally friendly, utilizing less toxic reagents like HOAc, minimizing waste and requiring no sophisticated equipment, making it a sustainable option for routine analysis.
Keywords
Felodipine,
stability-indicating assay,
UV-spectrophotometry,
degradation studies,
IR spectral analysis,
pharmaceutical and spiked human urine analysis
Supporting agencies: The authors wish to extend their sincere gratitude to JSS Mahavidyapeetha and the authorities of JSS College of Arts, Commerce and Science, Ooty Road, Mysuru, India, for providing the facilities necessary to conduct this research. Approval for conducting the urine analysis in this research was obtained from the Ethical Committee (ECR/387/Inst/KA/2013/RR-19), as per Letter No. JSS/MC/PA/5659/2024-25, dated November 6, 2024
About the Authors
R. Nagaraju
PG Department of Chemistry, JSS College of Arts, Commerce and Science (Research Centre Recognized by University of Mysore)
India
India
Rakshith Nagaraju
Mysuru, Karnataka
C. Siddaraju
PG Department of Chemistry, JSS College of Arts, Commerce and Science (Research Centre Recognized by University of Mysore); Maharani’s Science College for Women
India
India
Department of Chemistry.
Mysuru, Karnataka
H. C. Prameela
Maharani’s Science College for Women
India
India
Hullikal Chandrashekar Prameela - Department of Chemistry.
Mysuru, Karnataka
P. Chikkegowda
Department of Pharmacology, JSS Medical College, JSS Academy of Higher Education and Research
India
India
Prathima Chikkegowda
SS Nagar, Mysuru, Karnataka
N. Rajendraprasad
PG Department of Chemistry, JSS College of Arts, Commerce and Science (Research Centre Recognized by University of Mysore)
India
India
Nagaraju Rajendraprasad
Mysuru, Karnataka
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Review
For citations:
Nagaraju R., Siddaraju C., Prameela H.C., Chikkegowda P., Rajendraprasad N. Stability-Indicating Greener UV Spectrophotometric Method for Felodipine Assay in Pharmaceutical and Urine Samples and Comprehensive Degradation Studies with IR Spectral Analysis. Zhurnal Prikladnoii Spektroskopii. 2025;92(3):415.
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