A Rapid and Validated Reversed-Phase High-Performance Liquid Chromatographic Method with Pre-Column Derivatization and Fluorescence Detection for Quantification of Twenty Amino Acids in Total Parenteral Nutrition Solutions.

ABSTRACT: Accurate quantification of all 20 proteinogenic amino acids (AAs) is critical for the quality control of total parenteral nutrition (TPN) formulations containing complex excipient matrices. This study presents a rapid and validated reversed-phase high-performance liquid chromatography (RP-HPLC) method employing pre-column derivatization with 6-aminoquinolyl-N-hydroxysuccinimidyl carbamate (AQC) and fluorescence detection (FLD) for the simultaneous determination of AAs. Complete baseline separation of all 20 AAs was achieved within 18 minutes, with a total analytical run time of 25 minutes on a conventional HPLC system. The method was validated in accordance with ICH Q2(R2) guidelines, demonstrating excellent linearity (R2 > 0.999), high sensitivity (limits of detection = 0.02-0.16 μmol/L),

SUBMITTER: Konuklu D 

PROVIDER: S-EPMC12860203 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature