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Impurity Analysis of Lamivudine According to USP Method (CDBS-453)


According to the United States Pharmacopeia (USP), for the impurity analysis of Lamivudine, a column packed with L45 should be used. In the system suitability requirements, the resolution of lamivudine and the enantiomer should be no less than 1.5. ORpak CDBS-453, a USP L45 packing column, was confirmed to satisfy the requirements as per the analysis results below.

Sample : 10 µL
(System suitability solution) 0.25 mg/mL USP Lamivudine resolution mixture A RS in water
1. Lamivudine
2. Lamivudine enantiomer

Column       : Shodex ORpak CDBS-453 (4.6 mm I.D. x 150 mm)
Eluent       : Methanol and *Buffer (5 : 95) 
               *Buffer; 7.7 g/L of Ammonium acetate in water
Flow rate    : 1.0 mL/min
Detector     : UV (270 nm)
Column temp. : 25 °C 

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