Development and Evaluation of Chemometric Models for the Estimation of Sumatriptan in the Presence of Naproxen and a Degradation Product Using UV Spectrophotometry

Adel M Michael; Hayam M Lotfy; Mamdouh R Rezk; Christine K Nessim

doi:10.1093/jaoacint/qsae041

Development and Evaluation of Chemometric Models for the Estimation of Sumatriptan in the Presence of Naproxen and a Degradation Product Using UV Spectrophotometry

J AOAC Int. 2024 May 10:qsae041. doi: 10.1093/jaoacint/qsae041. Online ahead of print.

Authors

Adel M Michael¹, Hayam M Lotfy², Mamdouh R Rezk³, Christine K Nessim¹

Affiliations

¹ Pharmaceutical Chemistry Department, Faculty of Pharmacy, Ahram Canadian University, 12566, 6th October, Cairo, Egypt.
² Pharmaceutical Chemistry Department, Faculty of Pharmacy, Future University in Egypt, 11835 Cairo, Egypt.
³ Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt.

PMID: 38730542
DOI: 10.1093/jaoacint/qsae041

Abstract

Background: Chemometrics is a discipline that allows the spectral resolution of drugs in a pharmaceutical formulation along with degradation product and it is as an alternative to chromatographic methods.

Objective: Sumatriptan (SUM) is co-formulated with naproxen (NAP) and used in acute migraine attacks. SUM which has physiological importance has not been subjected to any stability-indicating chemometric approaches yet so there is a need for accurate and safe method for the assay of the cited drug in their preparation. SUM was determined in pharmaceutical formulation along with NAP and in presence of alkali-induced degradation product with simple and cost-effective multivariate approaches using spectrophotometric data. The greenness and blueness assessment was applied using different ecological metrics, including green analytical procedure index (GAPI), analytical greenness metric (AGREE), analytical eco-scale (AES) & new "blueness" evaluation using BAGI tool, respectively.

Methods: Three chemometric approaches were applied for the stability-indicating determination of SUM in presence of NAP. Classical least squares (CLS), Partial least squares (PLS) and Principal components regression (PCR), three multivariate calibration numerical models that were performed on the UV- spectra of the mixtures, were used to achieve the best resolution.

Results: Sumatriptan was analyzed with mean accuracies for PLS (100.29 ± 1.318) and for PCR (100.60 ± 1.564). The presented methods were compared and validated for their quantitative analyses. Moreover, statistical comparison between the results obtained by the proposed models and the official methods showed no significant differences.

Conclusion: The proposed multivariate calibrations were accurate and specific for quantitative analysis of the studied component. PLS is the best method that has the capacity for qualitative analysis of SUM and it is suitable for routine analysis and stability studies of it in quality control laboratories. Various ecological assessment metrics confirmed the long-standing eco-friendliness of the suggested models.