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Quantification of Alendronate Sodium Hydrate and Its Related Compound 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 and its related compound 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 and FMOC-4-aminobutyric acid. The system suitability requires to satisfy resolution ≥ 6 and relative standard deviation (RSD) of peak area ≤ 2.0% (repeated six times) for FMOC-alendronic acid and FMOC-4-aminobutyric acid. RSpak DS-413 was confirmed to satisfy all required conditions for the analysis of alendronic acid.


Sample : 20 μL
prepared according to JP
1. FMOC-Alendronic acid
2. FMOC-4-Aminobutyric acid


Column    : Shodex RSpak DS-413 (4.6 mm I.D. x 150 mm)
Eluent    : (A) 10 mM Trisodium citrate + 10 mM Na2HPO4 aq. (adjusted to pH 8.0 with H3PO4)
/CH3CN=85/15
(B) 10 mM Trisodium citrate + 10 mM Na2HPO4 aq. (adjusted to pH 8.0 with H3PO4)
/CH3CN=30/70
Linear gradient ; (B%) 0 to 50 % (0 to 20 min), 50 to 100 % (20 to 35 min),
100 to 0 % (35 to 36 min), 0 % (36 to 45 min)
Flow rate : 0.8 mL/min Detector : UV (266 nm) Column temp. : 45 °C

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