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Scholars Academic Journal of Pharmacy | Volume-9 | Issue-08
Simultaneous Method Development, Validation and Stress Studies of Darunavir and Ritonavir in Bulk and Combined Dosage Form Using UV Spectroscopy
Dr. K. Bhavyasri, M. Sreshta, Dr. M. Sumakanth
Published: Aug. 30, 2020 | 119 107
DOI: 10.36347/sajp.2020.v09i08.003
Pages: 244-252
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Abstract
A simple, specific, accurate and precise UV Spectrophotometric method has been developed for the simultaneous estimation of Darunavir and Ritonavir in pharmaceutical dosage form. The absorption maxima of the Darunavir and Ritonavir were found to be 267 nm by using methanol and 240nm using methanol: water as solvent and isosbestic point found at 254nm. This method obeys beers law in the employed concentration range of 2-18μg/ml and 5-100μg/ml for Darunavir and Ritonavir respectively. Different analytical validation parameters such as linearity, precision, accuracy, limit of detection (LOD) and limit of quantification (LOQ) were determined according to ICH guidelines. The accuracy of the method was confirmed by recovery studies of tablet dosage form and was found to be 100% and 99% for Darunavir and Ritonavir respectively. The LOD of Darunavir and Ritonavir was found to be 0.043μg/ml and 0.024μg/ml respectively and LOQ of Darunavir and Ritonavir was found to be 0.132μg/ml and 00.078μg/ml respectively. The developed method was free from interferences due to excipients present in formulation and it can be used for routine quality control analysis.