Bisphosphonate is a drug which prevents bone resorption, and thus used for osteoporosis treatment. According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (PF 47(6)*), ibandronate sodium hydrate assay should be carried out with an HPLC and a column filled with L23 packing material, and meets following requirements. The use of IC I-524A, an anion analysis column for non-suppressor method, confirmed the requirements were met.

System suitability requirements:
　Tailing factor: ≤ 2.5
   Relative standard deviation (RSD) of the peak area: ≤ 0.73%

*The version at the time of the application acquisition.


Sample : 40 μL
1. Ibandronate sodium 2 mg/mL
dissolved in H₂O

Columns      : Shodex IC I-524A (4.6 mm I.D. x 100 mm) x 2
Eluent       : 1 % Formic acid in water
Flow rate    : 0.58 mL/min
Detector     : RI (35 °C)
Column temp. : 35 °C