Analysis of Purified Sodium Hyaluronate Ophthalmic Solution According to JP Method (SB-802.5 HQ)
The 17th edition of the JP (Japanese Pharmacopoeia) came into effect on April 1, 2016. Purified sodium hyaluronate ophthalmic solution was added to the 17th 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