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Analysis of Insulin Glargine According to JP Method (KW-802.5)


Insulin glargine is an analogue of human insulin and is a biological medicine.
According to the Japanese Pharmacopeia (JP; 17th edition*), purity test of high-molecular proteins in insulin glargine should be carried with a column filled with hydrophilic silica gel and meets following requirements. The PROTEIN KW-802.5 confirmed the requirements were met.

System suitability requirements:
   Resolution of high-molecular proteins and insulin glargine: ≥ 1.5
   Relative standard deviation (RSD) of six analyses: ≤ 2.0%

*The version at the time of the application acquisition.

Sample : 100 μL
System suitability solution (prepared according to JP method)
1. High molecular weight proteins
2. Insulin glargine

Column       : Shodex PROTEIN KW-802.5 (8.0 mm I.D. x 300 mm) x 2
Eluent       : CH3COOH/CH3CN/H2O=20/30/50 (pH to 3.0 adjusted with 25 % NH3 aq.)
Flow rate    : 0.5 mL/min
Detector     : UV (276 nm)
Column temp. : 25 °C

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