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

According to the United States Pharmacopeia and the National Formulary (USP 42-NF 37*), "IMPURITIES: Limit of Lamivudine Enantiomer" for "Lamivudine" should be carried out with a column filled with L45 packing material. The ORpak CDBS-453, a column filled with L45 packing material, confirmed the requirement was met.

System suitability requirement Resolution between lamivudine and its enantiomer (System suitability solution): ≥ 1.5

*The version at the time of the application acquisition.

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

  1. 1.Lamivudine
  2. 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 ℃

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