Analysis of Purified Sodium Hyaluronate Ophthalmic Solution According to JP Method (SB-802.5 HQ)
According to the Japanese Pharmacopeia (JP; 17th edition*), analysis of purified sodium hyaluronate ophthalmic solution should meets following requirements. The OHpak SB-802.5 HQ confirmed the requirements were met.
System suitability requirements: Resolution of Hyaluronic acid /ε-Aminocaproic acid: ≥ 5 Relative standard deviation (RSD) of six analyses: ≤ 2.0%
*The version at the time of the application acquisition.
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