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