Determination of sodium hyaluronate injection by enzymatic hydrolysis-HPLC
10.19778/j.chp.2024.05.011
- VernacularTitle:酶解-高效液相色谱法测定玻璃酸钠注射液的含量
- Author:
Jing ZHANG
1
;
Tingting QIN
;
Xiaojie HAN
Author Information
1. 天津市药品检验研究院,天津 300070
- Keywords:
sodium hyaluronate;
enzymolysis;
HPLC;
hyaluronidase;
colorimetry;
assay
- From:
Drug Standards of China
2024;25(5):495-500
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a determination method for sodium hyaluronate injection.Methods:Sodium hyaluronate was specifically hydrolyzed by hyaluronidase,and the optimal enzymolysis conditions were enzymolysis at 37 ℃ for 4 h at 100 IU·mg-1 of enzyme reaction concentration.The analysis was performed on a of Shodex sug-ar SH1011 column(300 mm ×8 mm,6 μm)with a mobile phase of 1％H3PO4 at a flow rate of 0.6 mL·min-1.The eluent was detected at 230 nm.Results:Linear ranges were 101.38-1 013.76 μg·mL-1(r=0.999 5),RSDs of precision,stability and repeatability tests were lower than 1％,and average recovery was 100.4％,RSD=2.0％(n=9).The RAD of determination results of this method and colorimetric was 0.1％-1.2％.Conclusions:The method is accurate and reproducible,and can be used for the determination of sodium hyalur-onate injection.
