Method for detecting content, dissolution rate and releasing rate of memantine hydrochloride or analogues thereof in medicinal agent
A technology of memantine hydrochloride and release degree, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of high price, inconvenient use, generation of harmful waste gas, etc. Effect
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experiment example 1
[0048] Experimental example 1 detection method verification test:
[0049] 1. Validation of the method
[0050] (1) Chromatographic conditions and system suitability test
[0051] Instruments and reagents: Shimadzu high performance liquid chromatography (LC-20AT infusion pump, SIL-20AC autosampler, CTO-20AC column thermostat, RID-10A differential refractive index detector), Kromasil C8 column (250mnx4.6mm, 5μm), the mobile phase is methanol-0.05mol / L potassium dihydrogen phosphate solution (57:43), the flow rate is 1.0ml / min, the column temperature is 35°C, and the detection cell temperature is 40°C.
[0052] Under this chromatographic condition, the main peak shape of memantine hydrochloride is normal, and the retention time is about 8 minutes, which is relatively moderate. The number of theoretical plates is greater than 1500 based on the peak of memantine hydrochloride. The resolution of the memantine hydrochloride peak and adjacent impurity peaks met the analysis requir...
Embodiment 1
[0073] Embodiment 1: memantine hydrochloride tablet (specification: 10mg) assay
[0074] 1.1 Drugs and reagents:
[0075] Drugs: The test product is memantine hydrochloride tablets, produced by Zhuhai United Laboratories Co., Ltd. Zhongshan Branch; the reference substance memantine hydrochloride is from Zhuhai United Laboratories Co., Ltd.
[0076] Reagents: Potassium dihydrogen phosphate is of analytical grade, methanol is of chromatographic grade.
[0077] 1.2 Chromatographic conditions and system suitability test:
[0078] Chromatographic column: Kromasil C8 column (250mnx4.6mm, 5μm); methanol-0.05mol / L potassium dihydrogen phosphate solution (57:43) is used as the mobile phase, the detector is a differential refractive index detector, and the flow rate is 1.0ml per minute. The column temperature was 35°C, and the detection cell temperature was 40°C.
[0079] 1.3 Preparation of reference solution:
[0080] Accurately weigh about 20 mg of the reference substance, put it ...
Embodiment 2
[0088] Embodiment 2: memantine hydrochloride oral solution (specification: 120ml: 240mg) content determination
[0089] 2.1 Drugs and reagents:
[0090]Drugs: The test product is memantine hydrochloride oral solution, produced by Zhuhai United Laboratories Co., Ltd. Zhongshan Branch; the reference substance memantine hydrochloride is from Zhuhai United Laboratories Co., Ltd.
[0091] Reagents: Potassium dihydrogen phosphate is of analytical grade, methanol is of chromatographic grade.
[0092] 2.2 Chromatographic conditions and system suitability test:
[0093] Chromatographic column: Kromasil C8 column (250mnx4.6mm, 5μm); methanol-0.05mol / L potassium dihydrogen phosphate solution (57:43) is used as the mobile phase, the detector is a differential refractive index detector, and the flow rate is 1.0ml per minute. The column temperature was 35°C, and the detection cell temperature was 40°C.
[0094] 2.3 Preparation of reference solution:
[0095] Preparation of Reference Sub...
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