Detection method for starting material A in bulk drug of landiolol hydrochloride
A technology of landiolol hydrochloride and a detection method is applied in the field of detection of starting material A in the raw material medicine of landiolol hydrochloride, and can solve the problems affecting the use safety, detection interference and detection sensitivity of landiolol hydrochloride drug. Less than requirements and other problems, to achieve the effect of short detection time, low-cost detection, and ensure the safety of use
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Embodiment 1
[0034] Embodiment 1: the detection of starting material A in landipolol hydrochloride crude drug
[0035] Specific steps are as follows:
[0036] (1) Pretreatment of samples
[0037] Accurately weigh about 20.0 mg of landisolol hydrochloride raw material, put it in a 10 mL volumetric flask, add the dilution solvent to the scale, shake well, and ultrasonically for 10 minutes, transfer 1.0 mL to a centrifuge tube and centrifuge at 12,000 r / min for 10 minutes. Inject 5 μL of the supernatant for detection.
[0038] (2) Liquid chromatography-tandem mass spectrometry detection
[0039] High-performance liquid chromatography / mass spectrometer was used for detection, and the content of starting material A in the landiprolol hydrochloride raw material drug was calculated by the internal standard method.
[0040] The parameter conditions of the liquid chromatograph are:
[0041] XDB-C18 chromatographic column, column temperature: 30°C, injection volume 5 μL, flow rate 0.4mL / min, mob...
Embodiment 2
[0059] Embodiment 2: the methodological investigation of detection method of the present invention
[0060] 1. Exclusiveness
[0061] (1) Preparation of raw material blank sample of landyrolol hydrochloride (2.0mg / mL): Accurately weigh 20.0mg of blank landyrolol hydrochloride sample, put it in a 10mL measuring bottle, add diluting solvent to the mark, shake well and then sonicate 10 minutes, as a blank sample solution. Pipette 1.0mL into a centrifuge tube, centrifuge at 12000r / min for 10 minutes, take the supernatant and inject 5.0μL, and detect according to the detection conditions of liquid chromatography / tandem mass spectrometry in Example 1. The mass spectrogram is as follows: figure 2 shown.
[0062] (2) Preparation of the sample solution of Landisolol hydrochloride API spiked (starting material A): Accurately weigh 20.0 mg of Landisolol hydrochloride sample, place it in a 10 mL measuring bottle, and accurately add the concentration to be 2.0 mg / mL (S)-(+)-glycidyl m-...
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