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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 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