Development and validation of an analytical method for the determination of pyrroloquinoline quinone in magistral and commercial formulations for human use

Abstract

A UV/Vis spectrophotometric method was developed and validated for the determination of pyrroloquinoline quinone disodium salt (PQQ-2Na) in capsules and injectables for human use. PQQ-2Na was quantified by direct spectrophotometry (in the zero-order spectrum) at its absorption ^λmaximum of 248 nm, using purified water as the solvent. The evaluation of the analytical parameters followed the guidelines established in the Collegiate Board Resolution (RDC) No. 166 of July 24, 2017, by ANVISA, National Institute of Metrology, Standardization and Industrial Quality (INMETRO) as well as the international guidelines, Q2(R1) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Official Methods of Analysis of AOAC INTERNATIONAL. The method demonstrated linearity in the concentration range of 5.0–25.0 μg/mL, with a correlation coefficient (r) greater than 0.990. The limits of quantification and detection were determined to be 0.36 μg/mL and 0.12 μg/mL, respectively, demonstrating the sensitivity of the method. Precision was established with a relative standard deviation (RSD) below 1.9%, with a recovery of 100.45± 0.0250, within acceptable limits. The proposed method was selective, as the excipients did not interfere with the determination of PQQ-2Na. The method also demonstrated robustness, showing no significant interference within the variation range of the studied factors in the PQQ-2Na content. In summary, the developed and validated method proved to be reliable, simple, economical, and quick to apply, facilitating its use in routine analyses in quality control laboratories.

Keywords: PQQ, quality control, UV/Vis spectrophotometry.