ANALYTICAL QUALITY BY DESIGN IMPLEMENTATION OF RP-HPLC METHOD DEVELOPMENT FOR SUGAMMADEX SODIUM AND MONOHYDROXY SUGAMMADEX SODIUM DETERMINATION
Sugammadex Sodium is a compound used to reverse neuromuscular blockade in patients undergoing surgery with muscle relaxants like rocuronium and vecuronium. Ensuring product quality requires precise and accurate analysis of its content and impurities from raw materials. This study employs the Analyti...
Saved in:
| Main Author: | |
|---|---|
| Format: | Theses |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/82655 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | Sugammadex Sodium is a compound used to reverse neuromuscular blockade in patients undergoing surgery with muscle relaxants like rocuronium and vecuronium. Ensuring product quality requires precise and accurate analysis of its content and impurities from raw materials. This study employs the Analytical Quality by Design (AQbD) approach to develop a robust HPLC method for determining Sugammadex Sodium and Monohydroxy Sugammadex Sodium (SGT-R1) in active pharmaceutical ingredient raw material.
The RP-HPLC technique is developed by the AQbD approach and validated for determining Sugammadex Sodium and SGT-R1 as per ICH guidelines Q2 (R2). Critical method parameters (CMP) are selected based on risk assessment studies and optimized using the Box-Behnken. The optimum method involved using a Symmetry C18 column (250 x 4.6 mm, 5µ) with a mobile phase consisting of 0.025 mol/L phosphate buffer (pH 2.5) and acetonitrile, which was gradually injected at a flow rate of 0.28 mL/min and a column temperature of 30°C. The validation demonstrated excellent linearity (r = 0.9999 for Sugammadex Sodium, r = 0.9997 for SGT-R1). The recovery rates were 100.4% for Sugammadex Sodium and 109.1% for SGT-R1. The relative standard deviation (RSD) for nine replications was 0.48% for Sugammadex Sodium and 5.46% for SGT-R1. This research concludes that the development of an analytical method to determine the levels of Sugammadex Sodium and SGT-R1 using an AQbD approach has successfully yielded an optimal and validated method.
|
|---|