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

Alendronic acid is widely used for the treatment of osteoporosis. According to the JP method (17^th edition), quantification of alendronate sodium tablets 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 alendronate tablet.

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 Na2HPO4 aq.(adjusted to pH 8.0 with H3PO4)
               /CH3CN/CH3OH=75/20/5
Flow rate    : 0.9 mL/min
Detector     : UV (266 nm)
Column temp. : 35 °C