Analytical Quality by Design-Based Robust RP-HPLC Method for Quantitative Estimation of Pregabalin and Etoricoxib in...

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• A fixed-dose combination tablet containing pregabalin (75 mg) and etoricoxib (60 mg) was approved for managing prolonged back pain with neuropathic components.
• This formulation addresses the need for effective pain management in patients with complex pain profiles.

Purpose of the Study:

• To develop and validate an analytical method for quantifying pregabalin and etoricoxib in a fixed-dose tablet formulation.
• To employ analytical Quality by Design (QbD) principles to ensure a robust and efficient analytical method.

Main Methods:

• Utilized reversed-phase high-performance liquid chromatography (RP-HPLC) with a Phenomenex C8 column.
• Optimized the mobile phase composition (0.35% orthophosphoric acid-acetonitrile, 1:1 v/v) and flow rate (1 mL/min) at a detection wavelength of 220 nm.
• Applied Quality by Design (QbD) principles and Design of Experiments (DoE) to identify critical method parameters.

Main Results:

• The developed RP-HPLC method was successfully validated according to International Conference on Harmonization (ICH) Q2(R1) guidelines.
• The assay results for pregabalin and etoricoxib in the tablet formulation were 99.05% and 100.02% w/w, respectively.
• Achieved efficient separation with well-defined peaks and a simple mobile phase.

Conclusions:

• The QbD-assisted RP-HPLC method provides accurate and reliable quantification of pregabalin and etoricoxib.
• The method offers advantages such as shortened analytical time (2.65 min for pregabalin, 7.45 min for etoricoxib) and robustness.
• The QbD approach ensures consistent, dependable data generation, saving time and resources in pharmaceutical analysis.