*Associate Professor, Department of Pharmaceutical Analysis, Santhiram College of Pharmacy (Autonomous), Nandyal-518501, A.P., India. Email: ruthmanorama5@gmail.com
1Professor, Department of Pharmaceutical Analysis, Santhiram College of Pharmacy (Autonomous), Nandyal-518501, A.P., India. Email: muneer.pharma@gmail.com
2Associate Professor, Department of Pharmaceutical Sciences, Santhiram College of Pharmacy (Autonomous), Nandyal-518501, A.P., India. Email: chintalaparimaladevi@gmail.com
3Associate Professor, Department of Pharmaceutical Sciences, Santhiram College of Pharmacy (Autonomous), Nandyal-518501, A.P., India. Email: maheswari.kukutla@gmail.com
4Department of Pharmaceutical Sciences, Santhiram College of Pharmacy (Autonomous), Nandyal-518501, A.P., India. Email: asravani1612@gmail.com
5Department of Pharmaceutical Sciences, Santhiram College of Pharmacy (Autonomous), Nandyal-518501, A.P., India. Email: ranjiniranjaniamp143@gmail.com
6Department of Pharmaceutical Sciences, Santhiram College of Pharmacy (Autonomous), Nandyal-518501, A.P., India. Email: pudurumahi@gmail.com
7Department of Pharmaceutical Sciences, Santhiram College of Pharmacy (Autonomous), Nandyal-518501, A.P., India. Email: tgnagasunitha@gmail.com
8Department of Pharmaceutical Sciences, Santhiram College of Pharmacy (Autonomous), Nandyal-518501, A.P., India. Email: bparamesh011@gmail.com
OBJECTIVES: A Stability indicating UV spectroscopic method for the accurate, precise and robust estimation of Flunarizine Dihydrochloride in bulk and its dosage form and the stability studies was performed for the drug as per ICH Guidelines (Q2)(R1) Guidelines.
Materials & Methods: Flunarizine Dihydrochloride shown its maximum absorbance at 254 nm by using 25% v/v methanol. The calibration curve was drawn over a concentration range of 10-60 µg/ml with a correlation coefficient (r²) of 0.9992.
Results: The developed method was validated in accordance with ICH guidelines and shown acceptance for all the parameters. Accuracy was assessed through recovery studies and was found within 98-102%. stability studies were performed for the drug and its drug product was found to be stable at all stress conditions.
Conclusion: The stability studies were monitored and characterized to understand the stability profile of drug. This validated method can be readily applied for routine quality control analysis of Flunarizine dihydrochloride in bulk and pharmaceutical dosage forms.
KEYWORDS: Method development, Calcium channel blocker, Flunarizine dihydrochloride, stability studies.
How to cite this article: Manorama M, Muneer S, Devi CP, Maheswari, Sravani A, Ranjani VR, Mani P, Sunitha T, Paramesh B. Development and Validation of a Robust Spectrophotometric Method for the Determination & Stability Profiling of Flunarizine Dihydrochloride by UV-Visible Spectroscopy. Int J Drug Deliv Technol. 2026;16(13s): 622-628. DOI: 10.25258/ijddt.16.13s.69
Source of support: Nil.
Conflict of interest: None