Analysis of Purified Sodium Hyaluronate Ophthalmic Solution According to JP Method (SB-802.5 HQ)

The 17^th edition of the JP (Japanese Pharmacopoeia) came into effect on April 1, 2016. Purified sodium hyaluronate ophthalmic solution was added to the 17^th edition of the JP. According to the JP method, it is necessary for the system suitability to satisfy resolution (Rs) of Hyaluronic acid /ε-Aminocaproic acid of ≥ 5, and for the system repeatability to satisfy relative standard deviation (RSD) of ≤ 2.0% (repeated six times). It was confirmed that the all conditions were satisfied when OHpak SB-802.5 HQ was used for analysis.


Sample : 20 μL
System suitability solution (prepared according to JP method)
1. Hyaluronic acid
2. ε-Aminocaproic acid

Column       : Shodex OHpak SB-802.5 HQ (8.0 mm I.D. x 300 mm)
Eluent       : 0.1 M Na2SO4 aq.
Flow rate    : 1.0 mL/min
Detector     : UV (210 nm)
Column temp. : 40 °C