Detection method for related substances in memantine hydrochloride preparation
A memantine hydrochloride and detection method technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of poor separation ability, no chromophore, and low sensitivity of TLC method, and achieve accurate and reliable experimental data and high sensitivity , good reproducibility
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[0026] Example 1: Determination of related substances in memantine hydrochloride oral solution
[0027] Take this appropriate amount (approximately equivalent to 10mg of memantine hydrochloride), place it on a water bath and steam to about 1ml, add an appropriate amount of water and transfer to a 10ml test tube with a stopper, add 1ml of 5mol / L sodium hydroxide solution, shake well, and precisely add 1ml of chloroform. Vortex and mix for 5 minutes, let it stand for 5 minutes, and divide the chloroform layer as the test solution. Under the following selected chromatographic conditions: (Agilent 6820 gas chromatograph, Cerity QA / QC chromatographic workstation), a capillary column with polydimethylsiloxane as the stationary phase, hydrogen flame ionization detector, temperature programmed, Hold at 150°C for 5 minutes, increase to 260°C at a rate of 5°C per minute, and hold for 35 minutes. The detector temperature is 300°C, and the injection port temperature is 240°C. The numbe...
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[0033] Example 2: Determination of related substances in memantine hydrochloride tablets
[0034] Take an appropriate amount of this product, grind finely, accurately weigh the fine powder (about 10mg of memantine hydrochloride) and place it in a 10ml test tube with a stopper, add 1ml of water to dissolve, add 1ml of 5mol / L sodium hydroxide solution, shake well, and add chloroform precisely 1ml, vortex and shake for 5 minutes, let stand for 5 minutes, and divide the chloroform layer as the test solution. Under the following selected chromatographic conditions: (Agilent 6820 gas chromatograph, Cerity QA / QC chromatographic workstation), a capillary column with polydimethylsiloxane as the stationary phase, hydrogen flame ionization detector, temperature programmed, Hold at 150°C for 5 minutes, increase to 260°C at a rate of 5°C per minute, and hold for 35 minutes. The detector temperature is 300°C, and the injection port temperature is 240°C. The number of theoretical plates i...
Example Embodiment
[0038] Example 3: Determination of Related Substances in Memantine Hydrochloride Capsules
[0039] Take an appropriate amount of the contents of this product, grind it, and accurately weigh the fine powder (about 10mg of memantine hydrochloride) and place it in a 10ml test tube with a stopper, add 1ml of water to dissolve, add 1ml of 5mol / L sodium hydroxide solution, shake well, precision Add 1ml of chloroform, vortex and shake for 5 minutes, let it stand for 5 minutes, and divide the chloroform layer as the test solution. Under the following selected chromatographic conditions: (Agilent 6820 gas chromatograph, Cerity QA / QC chromatographic workstation), a capillary column with polydimethylsiloxane as the stationary phase, hydrogen flame ionization detector, temperature programmed, Hold at 150°C for 5 minutes, increase to 260°C at a rate of 5°C per minute, and hold for 35 minutes. The detector temperature is 300°C, and the injection port temperature is 240°C. The number of theor...
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