Ibandronate sodium, also known as hydroxy-3- (methylpentylamine) - propane-1,1-diphosphonic acid sodium, is a new drug used to treat hypercalcemia and osteoporosis induced by bone tumors. It is characterized by low dosage and good tolerability. [1]

Detecting small amounts of free phosphate and hypophosphite in ibandronate sodium injection can better control the quality of the drug. In the current drug standards, only the content of phosphate is measured. [2] The establishment of ion chromatography detection method in this experiment can simultaneously determine the content of phosphate and hypophosphite. This method has high sensitivity and good reproducibility.

Test condition instrument: ICS 5000 system; Analysis column: IonPac AS18, 7.5 µ m, 250 × 4 mm (P/N: 060549); Protective column: IonPac AG18, 13 µ m, 50 × 4 mm (P/N: 060551); Column temperature: 30 ℃; Rinsing solution: Potassium hydroxide (KOH) gradient rinsing: 0-20 min, 12 mmol/L KOH; 20.1-25 min, 50 mmol/L KOH; 25.1- 35 min, 50 mmol/L KOH; 35.1-40 min, flow rate of 12 mmol/L KOH: 1.00 mL/min; Quantitative Loop: 10 µ L Detection Method: Inhibited Conductivity Detection, Anion Automatic Electrolysis Continuous Regeneration Microfilm Suppressor ASRS 300 4 mm (P/N: 064554), Self Circulation Mode, Inhibited Current 124 mA

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