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Quantification of Alendronate Sodium Hydrate According to JP Method (DS-413)

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Alendronic acid is widely used for the treatment of osteoporosis.
According to the Japanese Pharmacopeia (JP; 17th edition*), quantification of alendronate sodium hydrate should be carried out with a column filled with styrene divinyl benzene copolymer gel and meets following requirements. The method also mentions to pretreat the alendronic acid by adding 9-fluorenylmethyl chloroformate to let the amino groups to form 9-fluorenylmethyloxycarbony (FMOC)-alendronic acid. The RSpak DS-413 confirmed the requirements were met.

System suitability requirements for FMOC–alendronic acid:
   Theoretical plate number: ≥ 1,500
   Symmetry factor: ≤ 1.5
   Relative standard deviation (RSD) of six analyses: ≤ 1.0%

*The version at the time of the application acquisition.


Sample : 10 μL
prepared according to JP
1. FMOC-Alendronic acid
Column       : Shodex RSpak DS-413 (4.6 mm I.D. x 150 mm)
Eluent       : 50 mM Trisodium citrate + 50 mM Na2HPO4 aq.(adjusted to pH 8.0 with H3PO4)
/CH3CN/CH3OH=70/25/5 Flow rate : 0.7 mL/min Detector : UV (266 nm) Column temp. : 35 °C