Force Degradation Study of Ritonavir by RP-HPLC Method
Main Article Content
Abstract
Background
Ritonavir is a widely used pharmaceutical compound, and its stability is crucial for its efficacy and safety. Evaluating degradation products and procedure-associated contaminants is essential to ensure the quality of Ritonavir in its dosage form.
Objective
To develop a simple, straightforward, and reproducible ultra-performance liquid chromatographic (UPLC) method for evaluating Ritonavir's degradation products and contaminants in a pharmaceutical dosage form.
Method
- Chromatographic Separation: Performed using Cosmosil –C18 (100 mm x 2.1 ID) 10µ column.
- Elution System: Gradient elution system using a binary mixture of Methanol and Water.
- Flow Rate:8 mL/min.
- Detection: Monitored and detected at 239 nm using a UV-3000M detector.
- Retention Time: Found to be 5.1 minutes.
- Stress Conditions: Ritonavir was subjected to hydrolytic (acid, alkaline, and water), oxidative, photolytic, and thermal stress conditions.
- Validation: Method performance was validated according to the guidelines set forth by the International Conference on Harmonization (ICH).
Results
The developed UPLC method effectively separated Ritonavir and its degradation products, with a retention time of 5.1 minutes. The method proved to be stable and reliable under various stress conditions.
Conclusion
The UPLC method developed is simple, straightforward, and reproducible, making it suitable for evaluating Ritonavir's degradation products and contaminants in a pharmaceutical dosage form, in line with ICH guidelines.