Quantification of Alendronate Sodium Hydrate According to JP Method (DS-413)
Alendronic acid is widely used for the treatment of osteoporosis. According to the JP method (17th edition), quantification of alendronate sodium hydrate should be done using HPLC with a column packed with styrene divinyl benzene copolymer gel. The method also mentions to pretreat the alendronic acid by adding 9-fluorenylmethyl chloroformate to treat the amino groups to form 9-fluorenylmethyloxycarbony (FMOC)-alendronic acid. The system suitability requires to satisfy TPN ≥ 1,500, symmetry ≤ 1.5, and relative standard deviation (RSD) of peak area ≤ 1.0% (repeated six times) for FMOC–alendronic acid. RSpak DS-413 was confirmed to satisfy all required conditions for the analysis of alendronic acid.
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