A stress degradation kinetic study of darunavir ethanolate bulk and tablet dosage form by uv spectrophotometry

• Published in: Asian Journal of Pharmaceutical Analysis Vol. 10; no. 4; pp. 213 - 217
• Main Authors: Vyas, Amitkumar J., Pandey, Meenakshi M., Patel, Ajay I., Patel, Ashok B., Patel, Nilesh K., Chudasama, Alpesh
• Format: Journal Article
• Language: English
• Published: Raipur Athena Information Solutions Pvt. Ltd 01.12.2020
• Subjects: Accuracy; Antiretroviral drugs; Drug dosages; Enzymes; Pharmaceuticals; Pharmacy
• ISSN: 2231-5667; 2231-5675
• DOI: 10.5958/2231-5675.2020.00039.3

Forced degradation is a process that involves degradation of drug products and drug substances at conditions more severe than accelerated conditions and thus generates degradation products that can be studied to determine the stability of the molecule[3].So the objective of this work was to develop a validated stress degradation kinetic method of Darunavir ethanolate by UV Spectroscopy also for the determination of Darunavir ethanolate in presence of its degradation products generated by subjecting the drug to forced degradation conditions under acid, alkali, thermal, oxidative and photolytic stress as per the ICH guidelines[4]. Table 1 Summary of force degradation Stress condition Time % Degradation Acidic 0.01 M HCL 24 hrs 33.80 Basic 0.01 M NaOH 24 hrs 37.50 Photolytic 24 hrs 27.66 Oxidative 1% H2O2 24 hrs 58.40 Thermal 24 hrs 27.66 Accuracy: % recovery for Darunavir ethanolate was found in range of 98.39 to 100.80. [...]the method is accurate as shown in table no. 2 Table 2: The LOD was found to be 0.52μg/ml and LOQ 1.60μg/ml. [...]LOD and LOQ is acceptable. The results of pharmaceutical formulations assert that the proposed method of Darunavir ethanolate aptly feasible for their determination without interfering the additives and excipients. [...]the proposed stability indicating method can be applied in pharmaceutical analysis for drug as well pharmaceutical dosage form stability monitoring and quality control.