Development and Validation of a UV-Visible Spectrophotometric Method for the Quantitative Estimation of Suzetrigine in Pharmaceutical Tablet Formulation

Suzetrigine is a non-opioid analgesic with recent approval for treatments of moderate-to-severe acute pain in adults. The current investigation aimed to develop and validate a simple, fast, accurate, precise, and cost-effective UV-Visible spectrophotometric method for the quantitative estimation of suzetrigine in pharmaceutical tablet formulation. The method was developed using methanol as the solvent system and the maximum absorption wavelength (λmax) was found to be 246 nm. Calibration graph was constructed over a concentration range of 5-30 µg/mL and revealed good linearity with regression equation y = 0.03145x + 0.00360, and correlation coefficient (R2 = 0.99). The method was validated for linearity, accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ), and robustness. The mean recovery was within the acceptable analytical range, and the repeatability and intermediate precision were within 2 % RSD. The LOD and LOQ values were 0.22 and 0.67 µg/mL, respectively. Small deliberate variations in analytical conditions had no significant effect on the absorbance. The simulated assay of the tablet formulation was determined to be 99.7% of the label. Overall, the UV-Visible spectrophotometric method was developed successfully with adequate linearity, accuracy, precision, sensitivity, and robustness, and may be used to give a cost-effective and readily available approach for the routine quantification of suzetrigine in pharmaceutical tablet preparations. The numerical results contained herein this manuscript are simulated data which are under development for research-project and need to be experimentally verified prior to being used as real laboratory data.