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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

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