Analysis of Alendronate Sodium Hydrate According to JP Method (2) (DS-413)

Alendronic acid is widely used for the treatment of osteoporosis. According to the Japanese Pharmacopoeia (JP XVII*), “(2) Related substances" for “Alendronate Sodium Hydrate" should be carried out with a column filled with styrene divinylbenzene copolymer. The RSpak DS-613 confirmed the requirements were met.

System suitability requirementsElution order (Solution for system performance): Alendronic acid,4-Aminobutyric acid
Resolution between alendronic acid and 4-aminobutyric acid (Solution for system performance): ≥ 6
Relative standard deviation (RSD) of the peak area of alendronic acid (Stadandard solution): ≤ 2.0% (repeated 6 times)

*The version at the time of the application acquisition.

Sample: 10 µL
(Solution for system performance) prepared according to JP method

  1. 1.Alendronic acid (FMOC-Alendronic acid)
  2. 2.4-Aminobutyric acid (FMOC-4-Aminobutyric acid)
Column
：Shodex RSpak DS-613 (6.0 mm I.D. x 150 mm)
Eluent
：(A); 10 mM Trisodium citrate + 10 mM Na2HPO4 aq. (adjusted to pH8.0 with H3PO4)/CH3CN=85/15
(B); 10 mM Trisodium citrate + 10 mM Na2HPO4 aq. (adjusted to pH8.0 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 ℃

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