Manipulation and Processing of Spectral Signals for the Assay of the Newly Authorized Mixture of Bupivacaine/Meloxicam Using Fully Green Solvents and a Comparative Green Evaluation Supporting the Greenness and Sustainability of the Developed Smart Spectrophotometric Methods.

ABSTRACT

BACKGROUND: The bupivacaine (BVC)/meloxicam (MLX) combination is the first extended-release dual-acting local anesthetic (DALA) that provides 72 h of postoperative pain relief. It reduces opioid use after surgery and manages pain better than BVC alone over 72 h, and overcomes surgical site inflammation with a new synergistic mode of action that combines BVC with a low dosage of MLX. OBJECTIVE: In today's pharmaceutical research, we take great care to only use non-toxic solvents that pose no threat to either humans or the environment. This work determines BVC and MLX simultaneously, utilizing water and 0.1 M HCl in water as solvents. Moreover, the eco-friendliness of the specified solvents and the whole method development steps was evaluated based on how user-friendly they were using four standard methodologies. METHODS: The developed spectrophotometric methods depended on either zero-order, derivative, or ratio spectra that only required simple mathematical handling. The current techniques include dual wavelength (DW), Fourier self-deconvolution (FSD), first derivative (D1), ratio difference (RD), and first ratio derivative (DD1). RESULTS: Linearity was confirmed over a concentration range of 50-700 µg/mL for BVC and 1-10 µg/mL for MLX. For BVC and MLX, the LOQs were 26.85-41.33 µg/mL and 0.21-0.95 µg/mL, while the LODs were 8.86-13.64 µg/mL and 0.06-0.31 µg/mL, respectively. For the full validation of the proposed methods, ICH (international conference on harmonization) criteria were followed. CONCLUSION: Current methods have the advantage of sticking to the basis of zero-order, derivative, or ratio spectra and needing just the barest minimum of data processing no complex software, lengthy stages, or transformations are needed. HIGHLIGHTS No spectrophotometric methods have been published for the simultaneous analysis of BVC and MLX. As a result, the newly developed spectrophotometric approaches have great relevance and originality in the field of pharmaceutical analysis.