A kind of high performance liquid chromatography analysis method of eplerenone related substance
A high-performance liquid chromatography and eplerenone technology, which is applied in analytical materials, material separation, measuring devices, etc., can solve the problems of no literature reports, unfavorable production control, unclear detection of impurity spectrum and impurity structure, etc. The specificity of the method, the effect of large positive progress and practical application value
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Embodiment 1
[0041] Detection equipment and chromatographic conditions:
[0042] High performance liquid chromatography: SSI Series 1500PUMP, Series 1500DAD detector
[0043] Chromatographic column: Hypersil C18 (150×4.6mm, 5μm); mobile phase: acetonitrile-methanol-0.01mol / L phosphate buffer with a volume ratio of 10:35:55 (adjust the pH value to 3.0 with phosphoric acid); detection wavelength : 243nm; flow rate: 1.0ml / min; column temperature: 30°C; injection volume: 20μl.
[0044] Experimental steps:
[0045] (1) Sample preparation:
[0046] Take an appropriate amount of eplerenone and known impurities A-J, ultrasonically dissolve and dilute with a mixed solution of acetonitrile and water with a volume ratio of 3:2 to make eplerenone about 0.5 mg / ml and impurities A-G about 5 μg / ml. ml and impurity H-J are about 50μg / ml solution, as the sample solution.
[0047] (2) Detection: Take the above sample solution, inject 20 μl of it, and record the chromatogram.
[0048] For a typical ch...
Embodiment 2
[0050] Detection equipment and chromatographic conditions:
[0051] High performance liquid chromatography: SSI Series 1500PUMP, Series 1500DAD detector
[0052] Chromatographic column: Hypersil C18 (150×4.6mm, 5μm); mobile phase: acetonitrile-methanol-0.01mol / L phosphate buffer with a volume ratio of 10:35:55 (adjust the pH value to 3.0 with phosphoric acid); detection wavelength : 243nm; flow rate: 1.0ml / min; column temperature: 30°C; injection volume: 20μl.
[0053] (1) Sample preparation:
[0054] Acid destruction: Take eplerenone tablet, grind it finely, take an appropriate amount of fine powder (about 25mg containing eplerenone), put it in a 50ml measuring bottle, add 10ml of 1mol / L hydrochloric acid solution, shake well, and heat in a water bath for 15 minutes , after cooling, add 10ml of 1mol / L sodium hydroxide solution for neutralization, then ultrasonically treat the mixed solution of acetonitrile and water with a volume ratio of 3:2 to dissolve eplerenone and di...
Embodiment 3
[0063] Detection equipment and chromatographic conditions:
[0064] High performance liquid chromatography: SSI Series 1500PUMP, Series 1500DAD detector
[0065] Chromatographic column: Hypersil C18 (150×4.6mm, 5μm); mobile phase: acetonitrile-methanol-0.01mol / L phosphate buffer with a volume ratio of 10:35:55 (adjust the pH value to 3.0 with phosphoric acid); detection wavelength : 243nm; flow rate: 1.0ml / min; column temperature: 30°C; injection volume: 20μl.
[0066] Experimental steps:
[0067] (1) Sample preparation: Take an appropriate amount of eplerenone, and use an appropriate amount of acetonitrile and water mixed solution with a volume ratio of 3:2 to sonicate to dissolve and dilute to make a solution containing about 0.5 mg per 1 ml, shake well, and use it as a sample solution.
[0068] (2) Detection: Take the above sample solution, inject 20 μl of it, and record the chromatogram.
[0069] For a typical chromatogram see Figure 8 .
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