Method for detecting related substances in sodium ibandronate injection
A technology for sodium ibandronate and a detection method, which is applied in the field of pharmaceutical analysis, can solve the problems of lack of separation ability of organic compound impurities, inability to accurately quantify, low sensitivity, etc., achieve low cost, easy control, and ensure safety and reliability sexual effect
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[0065] Embodiment 1 The methodological research of detection analysis method of the present invention
[0066] Various tests in this embodiment all adopt the following conditions:
[0067] Instrument: Waters e2695 liquid chromatograph-charged aerosol detector (CAD Veo RS)
[0068] Chromatographic column: SIELC Coresep SB chromatographic column, the specification is 4.6mm×150mm, 2.7μm
[0069] Mobile phase A: acetonitrile: water: trifluoroacetic acid (3:97:0.02)
[0070] Mobile phase B: acetonitrile: water: trifluoroacetic acid (15:85:0.2)
[0071] Thinner: water
[0072] Injection volume: 100μl
[0073] Column temperature: 25°C
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