Abstract
Aim and Objectives: The aim of the work is focused on the optimization of the high-performance liquid chromatography (HPLC) method for the determination of ninhydrin-positive substances in amino acids using HPLC technique in a single method. Since, most of the amino acids are widely used in the determination of Renal and Nutrition drug products exist independently in the monograph for each amino acid either by TLC or HPLC.Methods: The chromatographic separation was performed using sodium amino acid analysis cation exchange column using Sodium Eluent Na 315, Sodium eluent Na 425, and Sodium Eluent Na 640 as Mobile phase, performed by gradient program with detection of wavelength 570 nm using flow rate as 0.4 mL/min. The method has been evaluated using post-column derivatization technique (HPLC/Pinnacle PCX).Results: All the amino acids were eluted correspondingly at the individual retention time and the method shall be validated as per the ICH Q2R1 Guideline.Conclusion: The method has been successfully evaluated and developed for the analytical applications.
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