Separation and measurement method of besifloxacin hydrochloride and isomer of besifloxacin hydrochloride
A technology for besifloxacin hydrochloride and enantiomers, applied in the field of analytical chemistry, can solve the problems of complex pretreatment process, failure to find, poor operability, etc., and achieve simple sample pretreatment process, accurate separation and detection , the effect of strong operability
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[0027] Example 1
[0028] Apparatus and conditions
[0029] American Agilent 1260 high performance liquid chromatography system and workstation; automatic sampling;
[0030]
[0031]
Example Embodiment
[0032] Example 2
[0033] Experimental steps
[0034] The diluent or blank solution is the mobile phase phase A / phase B=55 / 45(V:V);
[0035] Take about 20 mg of besifloxacin hydrochloride raw material (prepared according to the method disclosed in Chinese patent CN 200880003118), accurately weigh it into a 10 mL brown measuring flask, dissolve and dilute to the mark with a diluent, and shake it up as the test solution.
[0036] Take the blank solution and the test solution separately, perform high performance liquid chromatography analysis according to the conditions of Example 1, record the chromatogram, and see the results figure 1 , figure 2 . figure 2 It shows that the separation and detection method of the present invention can separate besifloxacin hydrochloride and its enantiomers, and the high-performance liquid chromatograph shows a resolution of 3.56.
Example Embodiment
[0037] Example 3
[0038] Take about 20 mg of Besifloxacin Hydrochloride API (prepared in accordance with the method of CN 201310479217.0) for the test product, accurately weigh it into a 10 mL brown volumetric flask, dissolve it with a diluent ultrasonically and dilute to the mark, shake it, and use it as the test product solution.
[0039] Take the test solution, perform HPLC analysis according to the conditions of Example 1, record the chromatogram, and see the results image 3 .
[0040] image 3 It is proved that this method can be used for the quality monitoring of besifloxacin hydrochloride, and the high performance liquid chromatograph showed a resolution of 3.74.
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