Development and Validation of RP-HPLC Technique for the Determination of Abacavir Sulfate Using the QBD Approach

Compared to the traditional or conventional approach, the quality by design approach to method development, which emphasizes evaluating and minimizing risks, has the potential to produce a method that is more reliable and durable. Abacavir sulfate (ABS) is classified as an antiretroviral. The present work describes a quality-by-design (QbD) methodology-based HPLC technique for quantifying abacavir sulfate. This study utilized an efficient experimental design based on the Box-Behnken design to optimize three key components of an RP-HPLC method: mobile phase composition, pH, and flow rate. Employing a Quality by Design (QbD) approach, critical method parameters were fine-tuned. Chromatographic separation was conducted on an Agilent Technologies ZORBAX Stable Bond - C18, 80°A, 4.6 x 250 mm column, and an isocratic mobile phase comprising methanol: Phosphate buffer (pH 6) in a 70:30 v/v ratio was employed. Using an injection volume of 20 µL and a flow rate of 1 mL/min, detection was carried out at a 287 nm wavelength. The method that was developed showed a linear relationship (r² = 0.99). Values for robustness, precision, and ruggedness were all within the expected ranges (%RSD <2% for other parameters, and <1% for system precision). The approach based on Quality by Design (QbD) facilitates the creation of a space for operation and a space for design by integrating an extensive understanding of all method performance attributes and facilitates its optimization, thereby ensuring the consistent quality of the abacavir sulfate. Additionally, it entailed pinpointing potential failure while maintaining a seamless life cycle.