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Quantification of Alendronate Sodium Injection According to JP Method (DS-613)


Alendronic acid is widely used for the treatment of osteoporosis. According to the JP method (17th edition), quantification of alendronate sodium injection 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 ≥ 1500, symmetry ≤ 1.5, and relative standard deviation (RSD) of peak area ≤ 1.0% (repeated six times) for FMOC–alendronic acid. RSpak DS-613 was confirmed to satisfy all required conditions for the analysis of intravenous alendronate.

Sample : 50 μL
prepared according to JP
1. FMOC-Alendronic acid

Column       : Shodex RSpak DS-613 (6.0 mm I.D. x 150 mm)
Eluent       : 50 mM Trisodium citrate + 50 mM K2HPO4 aq.(adjusted to pH 8.0 with H3PO4)
Flow rate : 0.9 mL/min Detector : UV (265 nm) Column temp. : 40 °C

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