*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
2Department of Pharmaceutical Sciences, Santhiram College of Pharmacy (Autonomous), Nandyal-518501, A.P., India. Email: chintalaparimaladevi@gmail.com
3Department 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: kummarisusmitha964@gmail.com
Objectives: A simple, precise, robust stability-indicating UV spectroscopic method was developed for the determination of Daridorexant (DRX) in bulk and formulation, and to study the Degradation behaviour of the drug as per ICH Guidelines (Q2) (R1) guidelines.
Materials and Methods: Daridorexant shown its maximum absorbance at 271 nm using 50% v/v methanol. The calibration curve was drawn over a concentration range of 2-12 µg/ml with a correlation coefficient (r²) of 0.9991.
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%. Degradation studies were performed for the drug and its drug product in all stress conditions, and the amount of drug degraded was calculated.
Conclusion: The degradation products were monitored and characterized to understand the stability profile of drug. This validated method can be readily applied for routine quality control analysis of Daridorexant in bulk and pharmaceutical dosage forms.
KEYWORDS: Method development, Daridorexant, Degradation behaviour, Stability profile
How to cite this article: Manorama M, Muneer S, Devi CP, Maheswari K, Renuka KS, Supraja BR, Sumanth A, Deepika I, Hareesha G. Stability Indicating UV Spectroscopic Method Development and Validation of Daridorexant in API and its Prepared Pharmaceutical Dosage Form. Int J Drug Deliv Technol. 2026;16(12s): 676-683. DOI: 10.25258/ijddt.16.12s.80
Source of support: Nil.
Conflict of interest: None