Method for separating and determining dimers in minodronic acid
A technology of minodronic acid and determination method, which is applied in material separation, measuring device, analyzing materials, etc., can solve the problem of not truly reflecting the quality of minodronic acid samples, etc.
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Embodiment 1
[0039] The separation and determination method of dimer in the minodronic acid of the present embodiment:
[0040] 1) Add a mixture of buffered saline and methanol at a volume ratio of 90:10 to the minodronic acid sample, wherein the buffered saline contains 1mmol / L tetrabutylammonium bromide and 30mmol / L sodium pyrophosphate decahydrate The aqueous solution is adjusted with phosphoric acid to make the pH value of the buffered saline solution be 7.5 to obtain a minodronic acid test solution with a concentration of 0.1 mg / ml.
[0041] 2) mobile phase: the mixture of buffered saline solution and methanol in step 1; chromatographic column: AgilentEclipseXDBC 18 (4.6×250mm, 5μm); the flow rate of the mobile phase is 1.0ml / min; the detection wavelength is 230nm; the column temperature is 30°C; the injection volume is 50μL.
[0042] Using the above-mentioned mobile phase, the dimer was configured into a dimer reference solution with a concentration of 0.1 mg / ml, and a mixed referen...
Embodiment 2
[0045] The separation and determination method of dimer in the minodronic acid of the present embodiment:
[0046] 1) Add a mixture of buffered saline and methanol at a volume ratio of 90:10 to the minodronic acid sample, wherein the buffered saline contains 1mmol / L tetrabutylammonium bromide and 10mmol / L sodium pyrophosphate decahydrate The aqueous solution was adjusted with phosphoric acid so that the pH of the buffered saline solution was 7.8 to obtain a minodronic acid sample solution with a concentration of 0.1 mg / ml.
[0047] 2) mobile phase: the mixture of buffered saline solution and methanol in step 1; chromatographic column: WatersXbridge C 18 (4.6×250 mm, 3.5 μm); the flow rate of the mobile phase is 1.0 ml / min; the detection wavelength is 230 nm; the column temperature is 30° C.; the injection volume is 50 μL.
[0048] Minodronic acid and dimer mixed reference substance solution with a concentration of 0.1 mg / ml were prepared using the above-mentioned mobile phase...
Embodiment 3
[0050] The separation and determination method of dimer in the minodronic acid of the present embodiment:
[0051] 1) Add a mixture of buffered saline and methanol at a volume ratio of 90:10 to the minodronic acid sample, wherein the buffered saline contains 1mmol / L tetrabutylammonium bromide and 10mmol / L sodium pyrophosphate decahydrate aqueous solution, adjusted with phosphoric acid to make the pH of the buffered saline solution 7.5.
[0052] 2) Mobile phase: the mixture of buffered saline solution and methanol in step 1; chromatographic column: Yuexu Xtimate C 18 (4.6×250mm, 5μm); the flow rate of the mobile phase is 1.0ml / min; the detection wavelength is 230nm; the column temperature is 30°C; the injection volume is 50μL.
[0053] Minodronic acid and dimer mixed reference substance solution with a concentration of 0.1 mg / ml were prepared using the above-mentioned mobile phase. Carry out HPLC analysis according to the above conditions, record the HPLC chromatograms of mob...
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